Method and apparatus for the treatment of the intervertebral disc annulus

ABSTRACT

The present invention provides methods and devices for treating the annulus of an intervertebral disc. The methods and devices can employ an expandable treatment device which is deployed at least partially in the subannular space. Fixation devices and methods are also disclosed, which help to secure the treatment device in place.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.12/247,687, filed Oct. 8, 2008, which is a divisional of U.S. patentapplication Ser. No. 11/120,750, filed May 3, 2005, now U.S. Pat. No.7,615,076, issued Nov. 10, 2009, which is a continuation-in-part of U.S.patent application Ser. No. 10/352,981 filed Jan. 29, 2003, nowabandoned, and a continuation-in-part of U.S. patent application Ser.No. 10/327,106 filed Dec. 24, 2002, now U.S. Pat. No. 7,004,970, issuedFeb. 28, 2006, each of which are continuations-in-part of U.S. patentapplication Ser. No. 10/133,339 filed Apr. 29, 2002, now U.S. Pat. No.7,052,516, issued May 30, 2006, which is a continuation-in-part of U.S.patent application Ser. No. 09/947,078, filed Sep. 5, 2001, now U.S.Pat. No. 6,592,695, issued Jul. 15, 2003, which is a continuation ofU.S. patent application Ser. No. 09/484,706, filed Jan. 18, 2000, nowabandoned, which claims the benefit of U.S. Provisional Application No.60/160,710, filed Oct. 20, 1999. This application also claims, throughapplication Ser. No. 10/133,339 the benefit of U.S. ProvisionalApplication No. 60/309,105, filed Jul. 31, 2001. This application isalso related to, and claims the benefit of, U.S. patent application Ser.No. 10/075,615, filed on Feb. 15, 2002, now abandoned. All areincorporated herein by reference in their entirety.

TECHNICAL FIELD

The invention generally relates to methods and devices for the closure,sealing, repair and/or reconstruction of an intervertebral disc annulus,and accompanying delivery devices and tools, and their methods of use.The repair can be of an aperture in the disc wall, or a weakened or thinportion. The term “aperture” refers to a hole in the annulus that is aresult of a surgical incision or dissection into the intervertebral discannulus, or the consequence of a naturally occurring tear (rent). Theinvention generally relates to surgical devices and methods for thetreatment of intervertebral disc wall repair or reconstruction. Theinvention further relates to an annular repair device, or stent, forannular disc repair. These stents can be of natural or syntheticmaterials. The effects of said reconstruction is restoration of discwall integrity, which may reduce the failure rate (3-21%) of a commonsurgical procedure (disc fragment removal or discectomy), oradvantageously provide a barrier to intradiscal material migration.

BACKGROUND

The spinal column is formed from a number of bony vertebrae, which intheir normal state are separated from each other by intervertebraldiscs. These discs are comprised of the annulus fibrosus, and thenucleus pulposus, both of which are soft tissue. The intervertebral discacts in the spine as a crucial stabilizer, and as a mechanism for forcedistribution between adjacent vertebral bodies. Without a competentdisc, collapse of the intervertebral disc may occur, contributing toabnormal joint mechanics and premature development of degenerativeand/or arthritic changes.

The normal intervertebral disc has an outer ligamentous ring called theannulus surrounding the nucleus pulposus. The annulus binds the adjacentvertebrae together and is constituted of collagen fibers that areattached to the vertebrae and cross each other so that half of theindividual fibers will tighten as the vertebrae are rotated in eitherdirection, thus resisting twisting or torsional motion. The nucleuspulposus is constituted of soft tissue, having about 85% water content,which moves about during bending from front to back and from side toside.

The aging process contributes to gradual changes in the intervertebraldiscs. The annulus loses much of its flexibility and resilience,becoming more dense and solid in composition. The aging annulus may alsobe marked by the appearance or propagation of cracks or fissures in theannular wall. Similarly, the nucleus desiccates, increasing viscosityand thus losing its fluidity. In combination, these features of the agedintervertebral discs result in less dynamic stress distribution becauseof the more viscous nucleus pulposus, and less ability to withstandlocalized stresses by the annulus fibrosus due to its desiccation, lossof flexibility and the presence of fissures. Fissures can also occur dueto disease or other pathological conditions. Occasionally fissures mayform rents through the annular wall. In these instances, the nucleuspulposus is urged outwardly from the subannular space through a rent,often into the spinal column. Extruded nucleus pulposus can, and oftendoes, mechanically press on the spinal cord or spinal nerve rootlet.This painful condition is clinically referred to as a ruptured orherniated disc.

In the event of annulus rupture, the subannular nucleus pulposusmigrates along the path of least resistance forcing the fissure to openfurther, allowing migration of the nucleus pulposus through the wall ofthe disc, with resultant nerve compression and leakage of chemicals ofinflammation into the space around the adjacent nerve roots supplyingthe extremities, bladder, bowel and genitalia. The usual effect of nervecompression and inflammation is intolerable back or neck pain, radiatinginto the extremities, with accompanying numbness, weakness, and in latestages, paralysis and muscle atrophy, and/or bladder and bowelincontinence. Additionally, injury, disease or other degenerativedisorders may cause one or more of the intervertebral discs to shrink,collapse, deteriorate or become displaced, herniated, or otherwisedamaged and compromised.

Surgical repairs or replacements of displaced or herniated discs areattempted approximately 390,000 times in the USA each year.Historically, there has been no known way to repair or reconstruct theannulus. Instead, surgical procedures to date are designed to relievesymptoms by removing unwanted disc fragments and relieving nervecompression. While results are currently acceptable, they are notoptimal. Various authors report 3.1-21% recurrent disc herniation,representing a failure of the primary procedure and requiringre-operation for the same condition. An estimated 10% recurrence rateresults in 39,000 re-operations in the United States each year.

An additional method of relieving the symptoms is thermal annuloplasty,involving the heating of sub-annular zones in the non-herniated painfuldisc, seeking pain relief, but making no claim of reconstruction of theruptured, discontinuous annulus wall.

Some have also suggested that the repair of a damaged intervertebraldisc might include the augmentation of the nucleus pulposus, and variousefforts at nucleus pulposus replacement have been reported. The presentinvention is directed at the repair of the annulus, whether or not anuclear augmentation is also warranted.

In addition, there has been experimentation in animals to assess varioussurgical incisions with and without the direct surgical repair of theannulus. These studies were performed on otherwise healthy animals andinvolved no removal or augmentation of nucleus pulposus. The authors ofthese experiments conclude that direct repair of the annulus does notinfluence the healing of the disc.

The present inventors have found, advantageously and contrary toaccepted practice, that the annulus tissue may be sutured and thatannular healing may be facilitated by reapproximation, reinforcement,and/or support of annular tissue. Methods and devices for carrying outannular repair and/or reconstruction are a subject of the presentinvention.

BRIEF SUMMARY OF THE INVENTION

The present inventions provide methods and related devices forreconstruction of the disc wall in cases of displaced, herniated,thinned, ruptured, or otherwise damaged or infirm intervertebral discs.In accordance with the invention, a method is disclosed forintervertebral disc reconstruction for treating a disc having anaperture, weakened or thin portion in the wall of the annulus fibrosisof the intervertebral disc. Repair, reconstruction, sealing, occludingan aperture, weakened or thin portion in the wall of the annulus mayprevent or avoid migration of intradiscal material from the subannularspace.

The method of the invention includes, in one embodiment, the steps ofproviding a first delivery tool having a proximal end and a distal end,the distal end carrying a treatment device; providing at least onesecond delivery tool having a proximal end and a distal end, the distalend carrying a fixation element; introducing the distal end of the firstdelivery tool at least partially into subannular intervertebral discspace; deploying said treatment device; introducing the distal end ofsaid at least one second delivery tool at lest partially into subannularintervertebral disc space; and deploying at least one fixation deviceinto, or through, the wall of an annulus to hold said treatment deviceat least partially within the subannular intervertebral disc space; andremoving the delivery tools.

A fixation device useful for intervertebral disc reconstruction fortreating a disc having an aperture, weakened, or thin portion in thewall of the annulus fibrosis of said intervertebral disc, said device,in one embodiment comprises at least one anchor portion and at least oneband.

A treatment device, according to one embodiment, comprises a mesh patchthat radially expands in the subannular space.

The invention also comprises delivery tools for delivering fixationdevices and treatment devices, as well as kits comprising devices andtools.

The objects and various advantages of the invention will be apparentfrom the description which follows. In general, the implantable medicaltreatment devices are placed, positioned, and subsequently affixed inthe annulus to reduce re-extrusion of the nucleus or other intradiscalmaterial through an aperture by: establishing a barrier or otherwiseclosing or partially closing the aperture; and/or helping to restore thenatural integrity of the wall of the annulus; and/or promoting healingof the annulus. Increased integrity and faster and/or more thoroughhealing of the aperture may reduce future recurrence of herniation ofthe disc nucleus, or intradiscal material, from the intervertebral disc,and the recurrence of resulting back pain. In addition, it is believedthat the repair of the annular tissue could promote enhancedbiomechanics and reduce the possibility of intervertebral disc heightcollapse and segmental instability, thus possibly avoiding back painafter a surgical procedure.

Moreover, the repair of an aperture (after for example, a discectomyprocedure) with the reduction of the re-extrusion of the nucleus mayalso advantageously reduce adhesion formation surrounding the nerveroots. The nuclear material of the disc is toxic to the nerves and isbelieved to cause increased inflammation surrounding the nerves, whichin turn can cause increased scar formation (adhesions or epiduralfibrosis) upon healing. Adhesions created around the nerve roots cancause continued back pain. Any reduction in adhesion formation isbelieved to reduce future recurrence of pain.

The methods and devices of the present inventions may create amechanical barrier to the extrusion of intradiscal material (i.e.,nucleus pulposus, or nuclear augmentation materials) from the discspace, add mechanical integrity to the annulus and the tissuesurrounding an aperture, weakened, or thin portion of the wall of theannulus, and promote faster and more complete healing of the aperture,weakened or thin portion.

Although much of the discussion is directed toward the repair of theintervertebral disc after a surgical procedure, such as discectomy (asurgical procedure performed to remove herniated fragments of the discnucleus), it is contemplated that the devices of the present inventionmay be used in other procedures that involve access (whether induced ornaturally occurring) through the annulus of the intervertebral disc, orprophylactic application to the annulus. An example of another procedurethat could require a repair technique involves the replacement of thenucleus (nucleus replacement) with an implantable nucleus material toreplace the functioning of the natural nucleus when it is degenerated.The object of the invention in this case would be similar in that therepair would maintain the replacement nucleus within the disc space.

According to an embodiment of the invention, a sub-annular device can beemployed to repair an aperture, degenerated, weakened, or thin portionin an intervertebral disc annulus. The device can be secured in placewith one or more fixation elements, such as sutures or anchors which mayalso be used to re-approximate the tissues surrounding the aperture,degenerated, weakened, or thin portion. The invention, throughinvolvement of the sub-annular space and wall for the repair of theaperture has several advantages. The first advantage of a repair thatinvolves a sub-annular surface derives itself from the physical natureof a circular (or an elliptical) compressed chamber with a radius, likean intervertebral disc. Sealing the inside wall has the inherentadvantage of being at a smaller radius of curvature versus the outerwall and thus, according to LaPlace's Law, the patch would be subjectedto lower stresses at any given pressure, all else held equal.

Another advantage of utilizing the inner surface to accomplish sealingis that the natural pressure within the disc can enhance the seating ofthe device against the inner wall of the disc space. Conversely, if therepair is performed on the outer surface of the annulus there is aninherent risk of leakage around the periphery of the device, with theconstant exposure to the pressure of the disc.

Another advantage of the present invention in utilizing an inner surfaceof the annulus is the reduction of the risk of having a portion of thedevice protruding from the exterior surface of the annulus. Devicematerials protruding from the exterior of the annulus pose a risk ofdamaging the nerve root and/or spinal canal which are in closeproximity. Damage to these structures can result in continued pain,incontinence, bowel dysfunction and paralysis.

Some embodiments of the present invention may also incorporate theconcept of pulling the tissues together that surround the aperture, theinner surface, and the outer surface of the annulus to help close theaperture, increase the integrity of the repair, and promote healing.

An example of the technique and placement of the device according to oneembodiment of the invention is as follows:

1. A treatment device is actuated into a delivery configuration bydelivery device and passed through an aperture in the wall of theannulus, positioning a treatment device in the subannular disc space, asshown in FIG. 3A-3C.

2. The delivery device is actuated to deploy the treatment device, asshown in FIG. 3D.

3. Holding the treatment device in the deployed configuration, afixation instrument is employed to introduce one or more fixationelements into, or through, the annulus to secure the treatment deviceand subsequently removed, as shown in FIGS. 2, 5 and 6.

4. The delivery device is disengaged from the treatment device.

Several devices according to the present invention can be used topractice the above illustrative inventive steps to seal, reconstructand/or repair the intervertebral disc. In some of the representativedevices described herein, there is: a reconfigurable device (note:patch, stent, device, mesh, barrier, and treatment device are here usedinterchangeably) that has, in use, at least a portion of the device inthe sub-annular space of the intervertebral disc annulus; a means toaffix the at least a portion of the device to or within at least aportion of the annulus; a means to draw the patch or fixation deviceinto engagement with the annular tissue in tension to thereby helpreduce the relative motion of the surfaces of the aperture and/orannulus after fixation, and thus promote healing. Reducing motion of theannular surfaces may provide the optimal environment for healing.

Some of the concepts disclosed hereinbelow accomplish these objectives,as well as may advantageously additionally incorporate design elementsto reduce the number of steps (and time), and/or simplify the surgicaltechnique, and/or reduce the risk of causing complications during therepair of the intervertebral disc annulus. In addition, the followingdevices may become incorporated by the surrounding tissues, or to act asa scaffold in the short-term (3-6 months) for tissue incorporation.

In an exemplary embodiment, one or more mild biodegradable surgicalsutures can be placed at about equal distances along the sides of apathologic aperture in the ruptured disc wall (annulus) or along thesides of a surgical dissection or incision in the annular wall, whichmay be weakened or thinned. The sutures hold an expandable device to asubannular surface of the annulus.

Sutures are then drawn in tension and secured in such a fashion as todraw the expandable device into engagement with the annular tissue, andalso to help effect closure of the aperture, to enhance natural healingand subsequent reconstruction by natural tissue (fibroblasts) crossingthe gap now bridged by the device in the disc annulus.

In an exemplary embodiment, the method can be augmented by creating asubannular barrier in and across the aperture by placement of a patch ofbiocompatible material acting as a bridge or a scaffold, providing aplatform for traverse of fibroblasts or other normal cells of repairexisting in and around the various layers of the disc annulus.

Such biocompatible materials may be, for example, medical gradebiocompatible fabrics or fibers, biodegradable polymeric sheets, or formfitting or non-form fitting fillers for the cavity created by removal ofa portion of the disc nucleus pulposus in the course of the discfragment removal or discectomy. The prosthetic material can be placed inand around the intervertebral space, created by removal of thedegenerated disc fragments.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate illustrative embodiments of theinvention and, together with the description, serve to explain theprinciples of the invention.

FIG. 1 shows a primary closure of an opening in the disc annulus.

FIGS. 2A-2B show a primary closure with a stent.

FIGS. 3A-3D show an annulus stent being inserted into and expandedwithin the disc annulus.

FIGS. 4A-4C shows a perspective view of a further illustrativeembodiment of an annulus stent, and collapsed views thereof.

FIGS. 5A-5C show the annulus stent of FIG. 4A being inserted into thedisc annulus.

FIGS. 6A-6C show a method of inserting the annulus stent of FIG. 4A intothe disc annulus.

FIG. 7 shows an illustrative embodiment of an introduction device for anannulus stent.

FIG. 8 shows a variation of the device depicted in FIG. 7.

FIGS. 9A-9C show an exemplary introduction tool for use with the devicesof FIGS. 7 and 8 with a stent deflected.

FIGS. 10A-10B show a still further illustrative embodiment of an annulusstent employing secondary barbed fixation devices.

FIG. 11A shows a herniated disc in perspective view, and FIG. 11B showsthe same disc after discectomy.

FIGS. 12A-12G show a still further illustrative embodiment of anintroduced and expanded annulus stent/patch being fixated and theaperture reapproximated.

FIGS. 13A-13C schematically depict a still further embodiment of theinvention where an expandable stent/patch is tethered in situ using acinch line.

FIGS. 14A-14C schematically depict the patch of FIG. 13 being fixatedthrough use of a barbed surgical staple device and a cinch line.

FIGS. 15A-15C schematically depict a still further embodiment of theinvention where an expandable stent/patch is tethered in situ using acinch line.

FIGS. 16A-16C schematically depict the stent/patch of FIG. 15 beingfixated through use of a barbed surgical staple device that penetratesthe patch/stent and a cinch line.

FIG. 17 depicts an exemplary use of filler material within the apertureduring placement of a patch/stent tethered by a cinch line.

FIGS. 18A-18E show exemplary embodiments of various additionalpatch/stent fixation techniques.

FIG. 19 shows a still further illustrative embodiment of a stent/patchhaving a frame.

FIGS. 20A-20C show a still further exemplary embodiment of the inventionhaving external fixation anchors.

FIGS. 21A-21C show still further embodiments of the invention havingexternal fixation anchors.

FIGS. 22A-22C show still further embodiments of the invention havingexternal fixation anchors.

FIG. 23 shows a delivered configuration of fixation means that mayresult from the use of a single, or multiple, devices to delivermultiple barbs, anchor, or T-anchors sequentially or simultaneously.

FIGS. 24A-24B show an illustrative configuration of an anchor banddelivery device.

FIGS. 25A-25D show an anchor band delivery device comprising twodevices, each with at least one T-anchor (barbs) and band with pre-tiedknot and optional knot pusher according to illustrative embodiments ofthe invention.

FIG. 26 shows an anchor and band delivery device according to oneembodiment of the invention.

FIGS. 27A-27B show, respectively, a lateral view of a still furtherexemplary embodiment of the present invention having a braidedarrangement in a collapsed configuration and an axial view of theexemplary embodiment in an expanded configuration.

FIG. 28 shows a lateral view of the exemplary embodiment of FIG. 27A ina collapsed configuration mounted on an illustrative delivery device.

FIG. 29 shows a lateral cutaway view of the exemplary embodiment of FIG.27A in a collapsed configuration.

FIG. 30 shows a lateral cutaway view of the exemplary embodiment of FIG.27B in an expanded configuration.

FIG. 31 shows a lateral view of an illustrative delivery member as shownin the exemplary embodiment of FIGS. 29 and 30.

FIG. 32 shows a lateral view of an exemplary embodiment of the inventionin an expanded configuration subannularly.

FIG. 33 shows a transverse view of a treatment device mounted on adelivery tool in an unexpanded configuration in the subannular cavity.

FIG. 34 shows a transverse view of the treatment device being deployedinto an expanded configuration in the subannular cavity.

FIG. 35 shows a transverse view of the treatment device fully deployedand adjacent the annular wall.

FIG. 36 shows a transverse view of the placement of a fixation elementdelivery device into the deployed treatment device.

FIG. 37 shows a transverse view of the placement of a fixation elementthrough the treatment device and the annular wall.

FIG. 38 shows a transverse view of after affixing a fixation elementdelivered in FIG. 37 and partial removal of the fixation elementdelivery device.

FIG. 39 shows a transverse view of the fixation element after removal ofthe fixation element delivery tool.

FIG. 40 shows a transverse view of an additional fixation element lockedin place on the opposite side of the treatment device.

FIG. 41 shows a transverse view of the removal of the treatment devicedelivery tool.

FIG. 42 shows an transverse view of an illustrative embodiment of atreatment device mounted on a delivery tool in an unexpandedconfiguration in the subannular cavity.

FIG. 43 shows a transverse view of after affixing a fixation element tothe treatment device of FIG. 42.

FIG. 44 shows a transverse view of the placement of a fixation elementdelivery tool through the treatment device and the annular wall.

FIG. 45 shows a transverse view of the placement of an additionalfixation element through the treatment device and the annular wall.

FIG. 46 shows a transverse view after the removal of the fixationelement delivery tool.

FIG. 47 is a view of the anchor band delivery tool pre-deployment incross section.

FIG. 48 shows a detail of the distal end of the anchor band (fixationelement) delivery tool in cross section.

FIG. 49 shows a detail of the slide body and cannula anchor of anexemplary fixation element delivery tool in cross section.

FIG. 50 is a view of the anchor band delivery tool in cross sectionduring a deployment cycle.

FIG. 51 is a detail of the distal end of the anchor band delivery tooldepicted in FIG. 50.

FIG. 52 shows a detail of the slide body and cannula anchor of anexemplary fixation element delivery tool in cross section during adeployment cycle.

FIG. 53 shows a detail of the suture retention block and blade assemblyof the anchor band delivery tool.

FIG. 54 is a view of the anchor band delivery tool in cross sectionduring the cutting of the suture tether and release of the anchor band.

FIG. 55 shows a detail of the distal end of the anchor band deliverytool during release of the anchor band.

FIG. 56 shows a detail of the shows a detail of the suture retentionblock and blade assembly of the anchor band delivery tool during thecutting of the tether.

FIG. 57 depicts an illustrative embodiments of a therapeutic devicedelivery tool (TDDT)

FIG. 58 shows a detail of the distal end of the therapeutic devicedelivery tool with a therapeutic device mounted thereon.

FIG. 59 depicts the deployment of a therapeutic device using the TDDT.

FIG. 60 depicts a detail of the distal end of the TDDT during deploymentof a therapeutic device.

FIG. 61 depicts the TDDT during release of the therapeutic device.

FIG. 62 is a detail view of the distal end of the TDDT during release ofthe therapeutic device.

FIG. 63 is a plan view along the axis of an expanded exemplarytherapeutic device, showing the engagement of the TDDT latch.

FIG. 64 is a plan view along the axis of an expanded exemplarytherapeutic device, showing the disengagement of the TDDT latch.

FIG. 65 illustrates an exemplary sizing tool used to assess thetreatment site prior to delivery of patch, anchor bands or othertreatment devices.

FIGS. 66A-66C depict various configurations of an exemplary therapeuticdevice.

FIG. 67 shows an illustrative embodiment of a pre-set heat formedtherapeutic device in cross section through a longitudinal axis.

FIGS. 68A-68B show a therapeutic device with a single rib of materialaffixed to or formed on the device.

FIGS. 69A-69D show a therapeutic device with multiple ribs of materialaffixed to or formed on the device.

FIGS. 70A-70C illustratively show means that may be attached to theanchor band or anchor band delivery tool for providing perceptiblefeedback.

FIG. 71A-71G depict illustrative means for latching, locking orotherwise securing the treatment device in its final configuration.

FIGS. 72A-72B show a treatment device constructed of two bodies.

FIGS. 73A-73C show an illustrative example of multiple members forminginner and outer members of a treatment device.

FIGS. 74A-74B show alternative illustrative mechanisms of drawingtogether locking elements/anchors.

FIGS. 75A-75B show alternative illustrative attachment mechanisms wherea pledget element that initially resides on outer annular surface.

FIGS. 76A-76B show a cross section view of the delivery of a flowablematerial from the distal end of delivery device.

FIG. 77 illustrates an alternative method and device for theintroduction of material into the disc space via the fixation elementdelivery tool.

FIGS. 78A-78B depicts an anchor band assembly used to repair acircumferential tear in the annulus.

FIG. 79A-79B illustrate illustrative embodiments of the invention usedto treat meniscal tissue of the knee.

FIGS. 80A-80B illustrate an illustrative general surgical application ofthe invention for treating hernia.

DETAILED DESCRIPTION

Reference will now be made in detail to selected illustrativeembodiments of the invention, with occasional reference to theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

In the surgical repair of an aperture in the annulus, as shown in FIG. 1and as described in related commonly-assigned U.S. Pat. No. 6,592,625 toCauthen, a damaged annulus 42 is repaired by use of surgical sutures 40.One or more surgical sutures 40 are placed at about equal distancesalong the sides of a pathologic aperture 44 in the annulus 42.Reapproximation or closure of the aperture 44 is accomplished by tyingthe sutures 40 so that the sides of the aperture 44 are drawn together.The reapproximation or closure of the aperture 44 enhances the naturalhealing and subsequent reconstruction by the natural tissue (e.g.,fibroblasts) crossing the now surgically narrowed gap in the annulus 42.Preferably, the surgical sutures 40 are biodegradable, but permanentnon-biodegradable may be utilized. In all embodiments wherebiodegradable materials are indicated, suitable biodegradable materialsmay include, but are not limited to, biodegradable polyglycolic acid,swine submucosal intestine, collagen, or polylactic acid. Other suitablesuturing (and band) materials include, e.g., polymeric materials such aspolyethylene teraphthalate (PET), polyester (e.g., Dacron™),polypropylene, polyethylene, polycarbonate urethane or metallic materialinclude, e.g., titanium, nickel titanium alloy, stainless steel,surgical steels or any combinations thereof.

Additionally, to repair a weakened or thinned wall of a disc annulus 42,a surgical incision or dissection can be made along the weakened orthinned region of the annulus 42 and one or more surgical sutures 40 canbe placed at about equal distances laterally from the incision.Reapproximation or closure of the incision is accomplished by tying thesutures 40 so that the sides of the incision are drawn together. Thereapproximation or closure of the incision/dissection enhances thenatural healing and subsequent reconstruction by the natural tissuecrossing the now surgically narrowed gap in the annulus 42. Preferably,the surgical sutures 40 are biodegradable, but permanentnon-biodegradable materials may be utilized.

Where necessary or desirable, the method can be augmented by placing apatch in and across the aperture 44. The patch acts as a bridge in andacross the aperture 44, providing a platform for traverse of fibroblastsor other normal cells of repair existing in and around the variouslayers of the disc annulus 42, prior to closure of the aperture 44.FIGS. 2A-B, for example, show a biocompatible device employed as anannulus stent 10, being placed in and across the aperture 44. Theannulus stent 10 acts as a bridge in and across the aperture 44,providing a platform for a traverse of fibroblasts or other normal cellsof repair existing in and around the various layers of the disc annulus42, prior to closure of the aperture 44. In some embodiments the device,stent or patch can act as a scaffold to assist in tissue growth thathealingly scars the annulus.

In an illustrative embodiment, the annulus stent 10 is a solid unit,formed from one or more of the flexible resilient biocompatible orbioresorbable materials well know in the art. The selection ofappropriate stent materials may be partially predicated on specificstent construction and the relative properties of the material suchthat, after fixed placement of the stent, the repair may act to enhancethe healing process at the aperture by relatively stabilizing the tissueand reducing movement of the tissue surrounding the aperture.

For example, the annulus stent 10 may be made from:

A porous matrix or mesh of biocompatible and bioresorbable fibers actingas a scaffold to regenerate disc tissue and replace annulus fibrosus asdisclosed in, for example, U.S. Pat. Nos. 5,108,438 (Stone) and5,258,043 (Stone), a strong network of inert fibers intermingled with abioresorbable (or bioabsorbable) material which attracts tissue ingrowthas disclosed in, for example, U.S. Pat. No. 4,904,260 (Ray et al.).

A biodegradable substrate as disclosed in, for example, U.S. Pat. No.5,964,807 (Gan at al.); or an expandable polytetrafluoroethylene(ePTFE), as used for conventional vascular grafts, such as those sold byW.L. Gore and Associates, Inc. under the trademarks GORE-TEX andPRECLUDE, or by Impra, Inc. under the trademark IMPRA.

Furthermore, the annulus, stent 10, may contain hygroscopic material fora controlled limited expansion of the annulus stent 10 to fill theevacuated disc space cavity.

Additionally, the annulus stent 10 may comprise materials to facilitateregeneration of disc tissue, such as bioactive silica-based materialsthat assist in regeneration of disc tissue as disclosed in U.S. Pat. No.5,849,331 (Ducheyne, et al.), or other tissue growth factors well knownin the art.

Many of the materials disclosed and described above representembodiments where the device actively promotes the healing process. Itis also possible that the selection of alternative materials ortreatments may modulate the role in the healing process, and thuspromote or prevent healing as may be required. It is also contemplatedthat these modulating factors could be applied to material substrates ofthe device as a coating, or similar covering, to evoke a differenttissue response than the substrate without the coating.

Materials of the patch could include a metallic material (e.g., NiTialloy, Stainless steel, Titanium), or a polymeric material (e.g.,polypropylene, polyethylene, polyurethane, polycarbonate urethane,Polyetheretherketone (PEEK), polyester, PET, poly olefin copolymer,polypropylene, polyethylene), or a biodegradable or bioresorbablematerial (e.g., collagen, cellulose, polysaccharide, polyglycolic acid(PGA), a polylevolactic acid (PPLA), a polydioxanone (PDA) or forexample a racemic polylactic acid (PDLLA), or a combination of thesematerials.

In an illustrative method of use, as shown in FIGS. 3A-3D, lateralextensions 20 and 22 of a stent 10 are compressed together for insertioninto the aperture 44 of the disc annulus 42. The annulus stent 10 isthen inserted into the aperture 44, where the lateral extensions 20, 22expand. In an expanded configuration, the upper surface 28 cansubstantially conform to the contour of the inside surface of the discannulus 42. The upper section 14 is positioned within the aperture 44 sothat the annulus stent 10 may be secured to the disc annulus 42, usingmeans well known in the art.

In an alternative method, where the length of the aperture 44 is lessthan the length of the outside edge 26 of the annulus stent 10, theannulus stent 10 can be inserted laterally into the aperture 44. Thelateral extensions 20 and 22 are compressed, and the annulus stent 10can then be laterally inserted into the aperture 44. The annulus stent10 can then be rotated inside the disc annulus 42, such that the uppersection 14 can be held back through the aperture 44. The lateralextensions 20 and 22 are then allowed to expand, with the upper surface28 contouring to the inside surface of the disc annulus 42. The uppersection 14 can be positioned within, or proximate to, the aperture 44 inthe subannular space such that the annulus stent 10 may be secured tothe disc annulus, using means well known in the art.

It is anticipated that fibroblasts will engage the fibers of the polymeror fabric of the intervertebral disc stent 10, forming a strong wallduplicating the currently existing condition of healing seen in thenormal reparative process.

In an alternative embodiment, as shown in FIG. 4A, the annulus stent 10is substantially umbrella shaped, having a central hub 66 with radiallyextending struts 67. Each of the struts 67 is joined to the adjacentstruts 67 by a webbing material 65, forming a radial extension 76 aboutthe central hub 66. The radial extension 76 has an upper surface 68 anda lower surface 70, where the upper surface 68 contours to the shape ofthe disc annulus' 42 inner wall when inserted as shown in FIG. 6A-6C,and where the lower surface 70 contours to the shape of the discannulus' 42 inner wall when inserted as shown in FIG. 5A-5C. The radialextension 76 may be substantially circular, elliptical, or rectangularin plan shape.

As shown in FIGS. 4B and 4C, the struts 67 are formed from flexiblematerial, allowing the radial extension 76 to be collapsed for insertioninto aperture 44, then the expand conforming to the shape of the innerwall of disc annulus 42. In the collapsed position, the annulus stent 10is substantially frustoconical or shuttlecock shaped, and having a firstend 72, comprising the central hub 66, and a second end 74.

In an alternative embodiment, the radial extension 76 has a greaterthickness at the central hub 66 edge than at the outside edge.

In a method of use, as shown in FIGS. 5A-5C, the radial extension 76 iscollapsed together, for insertion into the aperture 44 of the discannulus 42. The radial extension 76 is folded such the upper surface 68forms the outer surface of the cylinder. The annulus stent 10 is theninserted into the aperture 44, inserting the leading end 72 though theaperture 44 until the entire annulus stent 10 is within the disc annulus42. The radial extension 76 is released, expanding within the disc 44.The lower surface 70 of the annulus stent 10 contours to the inner wallof disc annulus 42. The central hub 66 is positioned within the aperture44 so that the annulus stent 10 may be secured to the disc annulus 42using means well known in the art.

It is anticipated that fibroblasts will engage the fibers of the polymeror fabric of the annulus stent 10, forming a strong wall duplicating thecurrently existing condition of healing seen in the normal reparativeprocess.

In an alternative method of use, as shown in FIGS. 6A-6C, the radialextension 76 is collapsed together for insertion into the aperture 44 ofthe disc annulus 42. The radial extension 76 is folded such that theupper surface 68 forms the outer surface of the stent, for example in afrustoconical configuration as illustrated. The annulus stent 10 is theninserted into the aperture 44, inserting the tail end 74 through theaperture 44 until the entire annulus stent 10 is in the disc. The radialextension 76 is released, expanding within the disc. The upper surface68 of the annulus stent 10 contours to the disc annulus' 42 inner wall.The central hub 66 is positioned within the aperture 44 so that theannulus stent 10 may be secured to the disc annulus 42, using means wellknown in the art.

In one illustrative embodiment, the barbs 82 on the upper surface 68 ofone or more strut 67 or other feature of the radial extension 76, engagethe disc annulus' 42 inner wall, holding the annulus stent 10 inposition.

FIG. 7 shows a further aspect of the present invention. According to afurther illustrative embodiment, a simplified schematic cross section ofa vertebral pair is depicted including an upper vertebral body 110, alower vertebral body 112 and an intervertebral disc 114. An aperture orrent 116 in the annulus fibrosus (AF) is approached by a tube 118, whichis used to deliver a device 120 according to a further aspect of thepresent invention. The device 120 may be captured by a delivery tool 122through the use of a ring or other fixation feature 124 mounted on therepair device 120.

FIG. 8 shows a delivery method similar to that depicted in FIG. 7, withthe exception that the tube 118A has a reduced diameter so that it mayenter into the sub-annular space of the disc 114 through the aperture orrent.

Turning to FIGS. 9A-9C, according to a further aspect of the presentinvention, the delivery of the device 120 through the delivery tube 118or 118A may be facilitated by folding the arms or lateral extensions128, 130 of the device to fit within the lumen of the tube 118 or 118Aso that the stent or device 120 is introduced in a collapsedconfiguration. The device 120 is moved through the lumen of the tubes118 or 118A through the use of delivery tool 122. FIG. 9B shows the armsdeflected in a distal, or forward direction for insertion into thedelivery tube 118 or 118A while FIG. 9A shows the arms 128, 130deflected into a proximal position. FIG. 9C shows the device 120 curledso that one arm 128 is projecting distally, or in a forward direction,and the other arm 130 is projecting proximally, or in a rearwarddirection. Because the lateral extent of the device is relativelyflexible, whether the device is of natural or synthetic material, othercollapsible configurations consistent with the intent of this inventionare also possible, including twisting, balling, crushing, folding,bending, etc.

FIG. 10A shows an alternative fixation strategy where a pair of barbs134 and 136 are plunged into the annulus fibrosus from the exterior ofthe annulus while the device 120 is retained in the sub-annular space bymeans of a tether 142. Although there are a wide variety of fixationdevices in this particular example, a tether 142 may be knotted 145 withthe band 144 holding the barbs 134 and 136 together to fix the device inthe sub-annular space. The knot is shown in an uncinched position toclarify the relationship between the tether 142 and the bands 144. Usingthis approach, the device can be maintained in a subannular position bythe barbed bands while the tether knot is cinched, advantageouslysimultaneously reapproximating the annulus to close the aperture whiledrawing the device into sealing, bridging engagement with the subannularwall of the annulus fibrosus.

FIG. 10B shows an alternative fixation strategy where the barbs 148 and150 are sufficiently long that they can pierce the body of the device120 and extend all the way through the annulus fibrosus into the device120. In this configuration, the band 144 connecting the barbs 148 and150 may be tightened to gently restrain and position the device 120 inthe sub-annular space, or tightened with greater force to reapproximatethe aperture or rent.

Patches can be folded and expanded in a single plane or in threedimensions. As shown in FIGS. 9A-9C for example, collapsing the patchcan be accomplished laterally, whether the device is a single materialor composite. Others can collapse in three dimensions, such as thoseshown in FIGS. 4, 5, 27, 30 and 34. Devices which expand in threedimensions can optionally be packaged in a restraining sheath, jacket,gelatin shell or “gelcap”, or a mesh of biosorbable or dissolvablematerial, that would allow for facile placement and subsequentexpansion.

It is understood that there can be a variety of device designs ofpatches/stents/meshes/devices/treatment devices to accomplish theexpansion of a device from a first configuration, to a secondconfiguration to occupy at least a portion of the sub-annular space andreduce re-extrusion of the nucleus, or otherwise facilitate maintainingother intradiscal materials within the disc space. These devices can beconstructed of single components or multiple components, with a varietyof different materials, whether synthetic, naturally occurring,recombinated (genetically engineered) to achieve various objectives inthe delivery, deployment and fixation of a device to repair orreconstruct the annulus. The following device concepts are furtherdiscussed for additional embodiments of a device and/or system for therepair of an intervertebral disc annulus. The following descriptionswill illustratively depict and describe methods, devices, and tools todeliver a treatment to an intervertebral disc after a, lumbar discectomyprocedure; although, it is anticipated that these methods, devices, andtools may be similarly used in a variety of applications. As an example,the embodiments described herein may also advantageously maintainmaterials within the disc space other than natural disc tissue (nucleus,annulus, cartilage, etc.), such as implants and materials that may beused to replace and/or augment the nucleus pulposus or other parts ofdisc's tissues. These procedures may be performed to treat, for example,degenerative disc disease. Whether these materials are intended toreplace the natural functioning of the nucleus pulposus (i.e.,implantable prosthetics or injectable, in-situ curable polymer protein,or the like) or provide a fusion between vertebral bodies (i.e.,implantable bony or synthetic prosthetics with materials to facilitatefusion, such as growth factors like bone morphogenic proteins)-oneskilled in the art would realize that variations to the embodimentsdescribed herein may be employed to better address characteristicdifferences in the various materials and/or implants that could beplaced within the subannular space, and that these variations would bewithin the scope of the invention.

Furthermore, it should be noted that surgeons differ in their techniquesand methods in performing an intervention on a spinal disc, and theinventive descriptions and depictions of methods, devices and deliverytools to repair annular tissue could be employed with a variety ofsurgical techniques; such as, but not limited to: open surgical,microsurgical discectomy (using a magnifying scope or loupes), minimallyinvasive surgical (through, for example, a METRx™ system available fromMedtronic, Inc.), and percutaneous access. Surgeons may also employ avariety of techniques for intra-operative assessment and/orvisualization of the procedure, which may include: intra-operativeprobing, radiography (e.g., C-arm, flat plate), and endoscopy. It iscontemplated that the inventive embodiments described are not limited bythe various techniques that may be employed by the surgeon.

In addition, the surgical approach to the intervertebral disc throughoutthe figures and descriptions depict a common approach, with relatedstructures, to a lumbar discectomy; although, it is possible thatsurgeons may prefer alternative approaches to the intervertebral discfor various applications (for example, different intervertebral disclevels such as the cervical or thoracic region, or for nucleusaugmentation), which may include, but is not limited to:posterior-lateral, anterior, anterior-lateral, transforaminal,extra-foraminal, extra-pedicular, axial (i.e., through the vertebralbodies), retroperitoneal, trans psoas (through the Psoas muscle),contralateral. The approach to the intervertebral disc space should notbe interpreted to limit the use of the invention for the repair orreconstruction of the an aperture, weakened or thin portion of theannulus, as described herein.

It is also important to note that the boundary in the intervertebraldisc space between the annulus fibrosus and the nucleus pulposus asdepicted herein may be demarked or otherwise highlighted; however, it isimportant to recognize that these tissues are not as precisely demarkedin human tissues, and may be even less so as the patient ages or evincesdegeneration of the intervertebral disc. This demarcation may beespecially difficult to discern during an operative procedure, using forexample; available surgical tools (i.e., probes), fluoroscopic guidance(x-ray), or visual (endoscope) guidance. However, in general, the layersof the annulus have more structural integrity (and strength) than thenucleus, and this integrity varies from the outer most layers of theannulus being of higher structural integrity than the inner most layersof the annulus.

Moreover, the drawings and descriptions herein are necessarilysimplified to depict the operation of the devices and illustrate varioussteps in the method. In use, the tissues may be manipulated by, and arefrequently in contact with, the various tools and devices; however, forclarity of construction and operation, the figures may not show intimatecontact between the tissues the tools and the devices.

As depicted in FIG. 11A, a herniated disc occurs when disc nucleusmaterial emerges from the subannular region and outside of the disc.Herniated disc nucleus material then impinges on nerve tissue, causingpain. A discectomy attempts to relieve pressure on the nerve tissuethrough surgical removal of disc material, the result usually being anaperture in the disc annulus wall, and usually a void in the subannularspace where disc nucleus was removed, as shown in FIG. 11B. FIG. 11Btypifies a disc after the discectomy procedure has been performed, as domost of the drawings and descriptions contained herein. However, itshould be understood that in order to perform a discectomy procedure,there are a variety of instruments and tools readily available to thesurgeon during spine surgery, or other surgical procedures, to obtainthe outcome as shown in FIG. 11, or other outcomes intended by thesurgeon and the surgical procedure. These tools and instruments may beused to: incise, resect, dissect, remove, manipulate, elevate, retract,probe, cut, curette, measure or otherwise effect a surgical outcome.Tools and instruments that may be used to perform these functions mayinclude: scalpels, Cobb elevators, Kerrison punch, various elevators(straight, angled, for example a Penfield), nerve probe hook, nerveretractor, curettes (angled, straight, ringed), rongeurs (straight orangulated, for example a Peapod), forceps, needle holders, nerve rootretractors, scissors. This list is illustrative, but is not intended tobe exhaustive or interpreted as limiting. It is anticipated that some ofthese tools and/or instruments could be used before, during, or afterthe use of the inventive methods, devices and tools described herein inorder to access, probe (e.g., Penfield elevator), prepare (e.g., angledor ringed curette, rongeur, forceps), and/or generally assess (e.g.,angled probe) treatment site or facilitate the manipulation (e.g.,forceps, needle holder), introduction (e.g., forceps, needle holder,angled probe), or deployment (e.g., forceps, needle holder, angledprobe) of the treatment device and/or it's components.

The are a variety of ways to affix a device to the sub-annular wall ofthe annulus in addition to those discussed hereinabove. The followingexemplary embodiments are introduced here to provide inventiveillustrations of the types of techniques that can be employed to reducethe time and skill required to affix the patch to the annulus, versussuturing and tying a knot. Discussed hereinabove is the use of sutures,staples and other fixation devices to affix the patch to the annulus. Ina simple example, a patch/stent could be compressed, passed through aguide tube such as tubes 18, 18A shown in FIGS. 7 and 8, and expandedwithin the sub-annular space.

Another fixation means includes the passing of “anchoring band s” intothe wall of the annulus, vertebral bodies (superior, inferior, or both),or the Sharpey's Fibers (collagenous fibers between the junction of theannular fibers and vertebral bodies). In the following example ofanchors, the barbs or bands are affixed to the annulus/vertebralbodies/Sharpey's fibers. Another element, for example a suture, cinchline, or a staple is utilized to attach the anchor bands to the patch,and thus hold the patch in proximity to the inner wall of the annulus.In addition, these bands may re-approximate the tissues at the aperture.

Another example of fixating the device to inner wall of the annulus isfurther illustrated by FIGS. 12-14. As discussed hereinabove, withreference to FIGS. 7-10, a patch 120 is placed with a delivery tool 122,through the inner lumen of a guide tube 118, into the sub-annular spaceand then expanded. This step can also be seen in FIGS. 13 and 14, wherea patch 702 is folded and passed through a guide tube 706 and is held bya delivery tool 704. Also shown is a anchor band or staple 709 and ananchor band delivery device 708. Within the guide tube, or within thedelivery tool, there is a suture line or cinch line 710 that is attachedto the center of the patch 702. This can be seen in FIG. 12A with theguide tube 706 removed. As seen in FIGS. 13C and 14A, the guide tube 706is retracted after the patch 702 has been expanded and deployed. Next,as shown in FIGS. 12 and 14, an anchor band delivery tool 708 is used todeliver one or more “bands” 709 onto the outer surface of the annulus.These are intended to be anchored into the wall of the annulus with barbshapes that do not allow for the barbs to be pulled back through theannulus. The anchor bands resemble a construction of a “staple”. Thebands could actually be constructed by connecting two barbed elementswith, for example, a suture between the two barbed elements.

The barbs and the connection band between the barbs could be constructedof the same material or of different materials. For example, the barbedpart of the anchor band could be a biodegradable/bioabsorbable material(such as, for example, collagen, cellulose, polysaccharides,carbohydrates, polyglycolic acid, polylevolactic acid, polydioxanone,racemic polylactic acid) or could be constructed of a metallic orpolymeric biocompatible material (e.g., titanium, NiTi alloy, stainlesssteel, platinum, gold, polyurethane, polycarbonate urethane, polyimide,polyamide, polypropylene, polyethylene, polypropylene, polyester, PET,PEEK). The anchors could also be constructed of a combination of thesematerials. In addition, the band that connects these barbs can beconstructed of materials that are similar to the barbs, or differentmaterials. For example, the connection band could be abiodegradable/bioabsorbable suture, such as Vicryl, or a biocompatiblematerial such as polypropylene, polyethylene, silk, stainless steel,PET. In addition, it is possible that these elements are constructedfrom multiple materials to accomplish the objective of anchoring intothe annulus and providing for a fixation site to draw the tissuestogether.

FIGS. 12B and 12C show the placement of the anchor bands 709 into theannulus 712 with the anchor band delivery tool 708. FIGS. 14A and 14Bschematically show the placement of the anchor bands 709 into the wallof the annulus 712 and the retraction of the anchor band delivery device708, with the patch delivery tool 704 still in place. FIG. 12D depicts arepresentative anchor band 709, having a pair of stainless steel barbs709″ connected by a suture 709′. FIG. 12E shows the patch 702, anchorbands 709, and cinch line or suture 710 with the delivery tools removed,prior to drawing the patch and the tissues of the annulus together. Inthis embodiment there is a pre-fabricated slip knot 714 on the cinchline, although other locking elements or knots are possible. Sutureloops can connect to the barbs directly, as in FIG. 12, or loop tosurgical staples, or are placed directly into the annulus. The presenceof a pre-fabricated knot on the cinch line makes the process ofrepairing quicker since there is no need to tie a knot. It alsofacilitates drawing the tissues together. The use of the cinch line anda pre-fabricated knot can be placed by, for example, an external tubesuch as a knot pusher. FIG. 12E is similar to FIG. 10 describedhereinabove prior to “tying” the knot 714. FIG. 12F shows the drawing ofthe patch and the annular tissues together by pulling on the suture inthe direction “A” indicated by the arrow. In this case, the Knot Pusherhas been removed from the cinch line 710. The suture 710 is drawnproximally to draw the patch 702 into engagement with the inner wall ofthe annulus to seal the aperture from within, as well as draw the wallsof the annulus together to reapproximate the annular aperture. FIG. 14Cand FIG. 12G show the cinch line suture 710 tied and drawing the annulartissues together, after the excess suture line has been cut. It is alsoapparent from this device, fixation and delivery system that the outersurfaces of the aperture may be drawn together for re-approximation.

The cinching of the anchor bands and the patch also allows for taking-upthe slack that allows for the accommodation of varying sizes. Forexample, the thickness of the annular wall surrounding the aperture canvary from 1 mm up to 10 mm. Therefore, if the anchor bands have a setlength, this design with a cinch line accommodates different dimensionsof the thickness of the wall of the annulus by drawing the “slack” ofthe bands together within the aperture.

Although it has been described here as patch placement that involves twolateral anchor bands with a suture to draw the patch, bands and tissuestogether, one or two or more bands could be used and two bands is onlyan example. Furthermore, the anchor bands were placed with the barbs ina superior-inferior fashion. One skilled in the art would recognize thatthese could be placed at different locations surrounding the aperture,vertebral bodies or into the Sharpey's fibers.

Although the patch depicted in the example above does not have barbsattached to the patch, it is also possible to have the barbs asdescribed hereinabove to further promote the fixation of the patch tothe inner wall of the annulus.

Finally, although the drawings depict an aperture that lends itself tore-approximating the tissues, it is conceivable that some apertures,whether natural or surgically made, may be relatively large andtherefore might require the placement of additional material within theaperture to act as a scaffold for tissue in growth, between the patch onthe inner wall of the annulus and the anchor bands located on the outerwall. An example of material to fill the aperture might includeautograft para-spinal fascial tissue, xenograft, allograft, or othernatural collagenous materials. The filler material could also be of abiocompatible material such as a Dacron (polyester, or PET),polypropylene, polyethylene material. FIG. 17 shows the illustrativefilling of an aperture with implant material 716 prior to cinching thesuture 710.

As an alternative embodiment of the present invention, the anchor bands709 as described previously (anchor bands into annulus) could besufficiently long enough to pass through the annulus and then throughthe patch. The barbs in this embodiment have an engaging involvementwith the patch. This concept was previously discussed hereinabove inconnection with FIG. 10. Further illustration of such a system isschematically shown in FIGS. 15 and 16. Passing the barbs through thepatch, in this embodiment, provides additional security and safety byreducing the possibility that the barbs may migrate after implantation.In this application of the invention, the suture cinch line may (FIG.16C) or may not (FIG. 10B) be used in addition to the anchor bands todraw the tissues together and reduce tissue movement surrounding theaperture.

In addition, although the bands shown in FIG. 12 through 16 take theform of a “barb”, they could as easily take a form of a simple T-barb720, as shown in FIG. 18E, or a C-type element wherein the object is tohave irrevocable engagement with the patch device 702 after thepenetration through the patch. A T-type attachment, when alignedlongitudinally with the suture, passes through the patch. The T sectionthen rotates to prevent the suture anchor from being pulled back throughthe patch. In another embodiment a “C’ retainer made of a superelasticmaterial may be attached to the end of the suture band. The C retaineris loaded into a needle wherein it is held straight. The needle is usedto pass the C retainer and suture through the patch and deploy theretainer in a second configuration in the shape of a “C”.

It is also foreseen within the scope of the invention that there may bepatch designs which will accommodate the placement and securement of theanchor to the fabric that covers the frame of the patch. For example, aframe for a patch that is made out of metal such as Nitinol can providefor “windows”. The device, covered with a mesh fabric, for examplesilicone or Dacron, would therefore allow the anchoring barbs to bepassed through the “windows” in the frame of the patch. In this case,the barb can be secured to the patch in the fabric covering the frame.

Alternatively, the patch can be secured by passing barbs that engage thelattice of the patch frame. These embodiments of the inventionillustrate designs in which the barbs engage with the vertical,horizontal or criss-crossed structures/members of the frame. In thiscase, the barbs would pass through the mesh or lattice of the frame andthey would be unable to pass back out of the structure.

Although this discussion refers to “anchor bands” that are shown to betwo anchors connected by a suture, it is also contemplated that singlebarbs with sutures could be placed and the sutures' ends, at the outersurface of the annulus, are tied after placement through the patch. Itis also possible that these “single anchors” could be retained by asuture “pledget” on the outer wall of the annulus to better hold theouter surface, or could include a suture (or band) locking device.

One objective in the designs discussed hereinabove is to provide a wayto “pull up the slack” in a system to adjust the length of sutures andfor anchor bands. According to the present invention, a techniquereferred to as the “Lasso Cinch Knot” was developed as a means to drawthe anchor bands together with a suture cinch line that is incorporatedinto the patch design. FIG. 19 gives further description of the use ofthe Lasso embodiment. In essence, patch and frame constructs are usedthat incorporate the “barbs through the patch” design. Once the barbshave passed through the patch, an internal lasso 722 is drawn tightaround the sutures of the anchor bands and thus draws the extra suturematerial within the patch. The internal lasso gathers the sutures of thebands, and as the lasso is tightened, it cinches together the sutures ofthe bands and therefore tightens them and eliminates slack, bringing thepatch/stent into closer or tighter engagement with the annulus wall. Thepatch in FIG. 19 additionally provides for a diamond shape grid pattern,which advantageously provides a grid which will while allowing a probeor similar instrument to pass through with little resistance, providesresistance to a barb or other restraining feature on the instrument. Theframe shown can be made from nitinol, and the locking and holdingwindows shown at the center of the FIG. 19 would allow for rotationabout the z-axis during placement. A slipknot technique using, forexample a knot pusher, would aid in the loop pulling process by thelasso. The internal loop (lasso) can be tacked to the outside corners ofthe patch/stent, in order to hold the loop at the outer edges of thepatch frame. When cinching the lasso knot, the loop can be pulled freefrom some or all of its tacked attachment points to the frame, toprevent deformation of the planar shape of the frame when cinching thelasso. As above, the frame can be a composite structure or sandwichformed with some type of mesh fabric. The proximal mesh fabric can bebonded fully to the patch frame, for example through the use of anadhesive, for instance a silicone. Adhesive, advantageously, can fillthe interstices of the grid pattern while allowing for easy probepenetration and protection of the suture lines. Protection of the suturelines is advantageous when the lasso is used to pull and bunch a groupof band sutures together.

It is also contemplated within the scope of the present invention thatsutures or bands 710′ can be preattached directly to a stent/patch. Asshown in FIG. 18A several separate barbs 709″ into the annulus 712 canbe directly attached to the patch 702. Each “barb” of FIG. 18A can beindependently placed into the annulus after the patch is deployed.

An alternative embodiment for securing a patch 902 and reapproximating arent or incision is to provide each of the separate barbs with sutureshaving variable lengths as shown in FIG. 20. Each independent suturebarb 904 is placed into the annulus 906 or into the patch 902 with thebarb delivery tool 908. After the placement, all of the suture lines 910are drawn taught, by drawing on the free ends that exit the patchdelivery tool 912. A locking element (which may be referred to as alocking clamp, or band locking device, or band retention device) 914that uses a gasket 915 and threading mechanism within is attached to thepatch 902 and is used to tighten the gasket 915 around the distal endsof the sutures 910. The patch delivery tool 912 is removed and the extrasuture length is cut. It is also possible that the gasket mechanismcould be a press-fit to accommodate the tightening of the sutures to thepatch.

Alternatively, the locking mechanism can be as shown in FIG. 21,although in this case the engagement of the locking element 914′ takespart on the anchor. Pulling the tether 910 in the direction of arrow Bwill tighten and lockingly hold in tension to aid in securement andtissue approximation. The adjustable length band between the two anchorsallows slack to be taken up between the anchors 916. Two T-type anchorsare illustratively shown in this example, but multiple anchors ofdiffering configurations could be used. The locking features can beincluded on the feature band, as depicted here, and allow forsubstantially one-way locking engagement with the anchor members. Thisadjustability advantageously promotes for the accommodation of varyingthickness of the annulus from patient to patient. The suture/band slackin this embodiment may be taken up to close the defect in the annulusand/or to shorten the band between anchors for a secondary cinching ofmultiple tensioned suture bands as described herein.

FIG. 22 shows alternative embodiments for tightening “anchoring barbs”with different configurations of sutures and cinch lines. For example inFIG. 58B each independent barb has a looped suture attached to it.Through each of these loops is passed a cinch line, which contains aknot. After placement of the barbs within the annulus, and possiblythrough the patch, the cinch line draws the loops of the barbs together.The advantage of this embodiment is that it allows for the independentplacement of multiple barbs and the ability to draw all of themtogether.

Although cinch lines have been described as using a knot to “lock” thelength of the suture, other mechanisms could also lock the length, asshown in FIG. 21. The locking of the suture length is accomplishedthrough a mechanical element located on the barb which engages withthree dimensional elements attached to the suture line whichmechanically press fit through the engagement element on the barb, thuslocking the length of the suture line into place.

Although the embodiments of FIG. 21 and FIG. 22 depict the use of asingle locking mechanism (e.g., knot on cinch line), it is conceivablethat various designs could use more than one locking element to achievethe re-approximation and drawing together the tissue surrounding anaperture.

Similarly, an alternative embodiment to cause tension within the deviceand draw the tissues together after placement of the anchor bands mightinclude an elastic band or band with a spring which one end can beattached to the anchor bands and the other end attached to the patch.Alternatively, the anchor bands might, in and of themselves may be madeof an elastic band between the barbs, or may contain a spring elementbetween the barbs. Such an embodiment can be made to resemble aso-called “Bobber Spring.” Again, it is contemplated that the elastic orresilient element could be made from a wide variety of metals,polymeric, or biodegradable/bioabsorbable material.

As previously mentioned, the present invention also encompasses deliverydevices or tools of the following description. The delivery devices ofthe present invention are configured to deliver at least one, or aportion thereof, device into (or through) the annulus or other surfaceor tissue. The delivery tools (or devices) will typically comprisedevices or shafts having proximal and distal ends. As referred toherein, the proximal portion of a device or tool or component willgenerally refer to the portion of the device/tool/component that islocated furthest away from the patient (and closest to the surgeon);whereas, the distal portion will generally refer to the portion that iswithin (in use), or closest to the patient (and therefore furthest awayfrom the surgeon). Although some of the device descriptions may refer tosome fixation element embodiments as being “fixation” or “anchor/anchorband/barb”, this is done for clarity reasons and should not bemisconstrued to suggest that the device is not capable of alsoperforming a treatment and/or a repair.

In addition, the following descriptions of delivery devices/tools aregenerally intended to be single-use and disposable; however, it is clearthat these tools could as easily be constructed to be partially, orwholly, re-usable and re-sterilizable.

An illustrative delivery device as depicted in FIGS. 24-26 may beconfigured to accommodate and deploy at least one fixation device, suchas a barb or T-anchor with one or more associated bands. Advantageously,the distal end of the delivery device will comprise a hollow needle orcannula 711, having a circular, elliptical, triangular, hexagonal orother inner cross sectional area, suitable to accommodate thecross-sectional shape of the fixation device within. The distal point ofthe cannula 711 is advantageously sharpened, as a needle, to accommodateinsertion. The cannula 711 is advantageously cut obliquely as shown inFIG. 26 to form a sharp leading surface or point for ease of insertion.The cannula 711 may contain a cut or groove 718 along its side toaccommodate one or more anchors 709 as shown (or barbs, not shown),e.g., in FIG. 24B or 26. In one embodiment, the at least one fixationdevice (including band and barb or T-anchor), or portion thereof, isdisposed within the cannula 711 as shown in FIGS. 24 a, 24 b, and/or 26.Alternatively, the T-anchor 709 (or barb, not shown), or other fixationdevice may be hollow and disposed in a manner surrounding the device ofthe delivery device.

The delivery device 708 will also advantageously contain within it anejection rod 715. The proximal end of the ejection rod 715 typicallywill contain an end portion 713 to function as a stopper, e.g., having adiameter larger than the remaining portion of the rod, such as is shownin FIG. 24 a. The diameter of the remaining portion of the ejection rod715 will be small enough for insertion within the shaft of the device708. Upon insertion of the cannula 711 into the location of choice, theejection rod is pushed to deliver the fixation device. The deliverydevice is then removed.

Advantageously, the ejection rod 715 and delivery device may beconfigured to deliver multiple fixation devices, sequentially orsimultaneously. Thus, if multiple fixation devices are contained withinthe device, the ejection rod 715 and delivery device may be configuredsuch that the rod 715 be pushed a first distance, sufficient to delivera first fixation device. The device is then removed from the firstinsertion point and inserted into a second insertion point, where theejection rod is then pushed a second distance for delivery of a secondfixation device, and so-on as desired. For simultaneous delivery ofmultiple fixation devices, multiple delivery devices may be arranged inparallel (or substantially parallel). The distance between (or among)the delivery devices may be fixed or adjustable, as desired.

The distance the ejection rod 715 is pushed to define a first, second,and subsequent distances may be regulated by feel. Alternatively, thedistance can be regulated by the architecture of the device. Forexample, the shaft and ejection rod may be fitted with anotch-and-groove configuration, respectively. In such configuration, thenotch in the outer surface of the ejection rod may be aligned with agroove in the inner surface of the device. The length of the groovedefines a first distance. The ejection rod 715 would be then turned orrotated within the device, aligning the notch within the device to asecond groove defining a second distance, and so-on. In an alternativeembodiment, the ejection rod and anchor portion of the fixation device(e.g., barb or T-anchor) may surround the shaft of the device, as asleeve surrounds an arm. In such a configuration, the delivery toolwould comprise a solid shaft and the ejection rod and fixation devicewould be at least partially hollow and disposed over the distal portionof the delivery device. Pushing the ejection rod in a proximal to distaldirection would deploy the anchor portion of the fixation device.

FIGS. 24A and 24B describe one embodiment of an anchor band deliverydevice 708 and fixation means. FIG. 24A shows a general drawing of adelivery device. FIG. 24 b further depicts the distal end of thedelivery device. Anchor band delivery device 708 contains two pointedneedles or cannulas 711. Each cannula 711 contains an anchoring T-typeanchor 709 (or barb) positioned within the distal end of the cannula711. A band 709′ links the two anchors 709 (or barbs) together and acinch knot 714 secures the anchors (or barbs). Cinch line 710 is pulledto decrease the length of the band 709′ that attaches the anchors 709.

Referring to FIG. 25A, anchor band delivery device 708 is inserted intothe annulus 712 sufficiently to engage the inner layers of the annulus712, and preferably located at the inner wall of the annulus 712. Theanchors 709 are ejected from the delivery device by pressing theejection rod 715 in a fashion to expel the T-anchors 709 (or barbs, notshown) from the device. For example, pressing on the proximal end ofejection rod 715 as shown in FIG. 24A drives the ejection rod 715 in adistal direction, thus expelling the anchor from the device. FIG. 25Bshows the anchors 709 (or barbs) after being ejected. FIG. 25C shows aknot pusher 716 attached to the delivery tool 708 that can be used totighten the knot 714 once the fixation device is secured into theannular tissue. FIG. 25C shows the placement of two anchors 709, orfixation devices (anchors and bands), after they have been delivered tothe annulus and before the bands 709 have been tightened. The knotpushers 716 of both devices are still in contact with the knots and thedelivery needles have been pulled back, away from the annulus. FIG. 25Dshows the final placement of the two anchor bands after drawing togetherthe tissues surrounding the aperture 717, the inner wall of the annulus712, and/or the outer wall of the annulus; and, after tightening andcutting the knot located on each anchor band. Although this FIG. 25shows the passage of the bands superior and inferior to the aperture,these bands could also be placed in a multitude of locations to effectdesired or equivalent outcomes.

In addition, as previously described, one could use barbs having amultitude of configurations. One could also configure delivery devicesto deliver one (as in FIG. 26), two (as in FIG. 24A), or more barbssimultaneously, and according to predetermined or variable distances orpatterns. The delivery devices may also be configured to eject one, two,or more barbs sequentially. Further, the barbs could be delivered by adelivery device that does not require a cannula to cover the barb. Insuch a configuration, the barb may be disposed on the tip or outside ofthe delivery device's shaft, and removed therefrom upon injection intothe desired location of the annulus or other tissue. Bands and knots maybe pre-tied to accommodate each configuration, as previously discussed.

For example, although FIGS. 24 and 25A-B depict a device that places twoanchors 709 banded together with one device, one could accomplish anequivalent or other desired result with a single device that deliversmultiple barbs at the same time.

FIG. 26 shows an alternative delivery device that delivers two or moreanchors (or barbs) from a single cannula 711. In this embodiment, afirst single anchor 709 is ejected from the cannula 711 by pushing theejection rod 715 a first distance sufficient to eject the first anchor709, but insufficient to eject the second. Then the delivery device isremoved from the first site and passed into another annular location.The second anchor (or barb), not shown, connected to the first anchor orbarb by band, is ejected out of the cannula 711 by pushing the ejectionrod 715 an additional distance sufficient to eject the second anchor709″ (or barb) into a second fixation point in the annulus.

Although much of this description has described placement of the anchorsinto the annulus (or soft tissue) of the disc, one could performanchoring into other tissues surrounding the aperture, including thebone or Sharpey fibers, it is also contemplated that, given the deliverydevice construction, a bone drill or similar device may be necessary tofacilitate the placement of the delivery device through the bony orsimilar tissue.

The band 709′ connecting the thus implanted anchors (or barbs)advantageously contains a moveable knot 714 between the anchors.Suitable knots include, but are not limited to, the Roeder knot and itsfunctional equivalents, and are advantageously, but not necessarily,pre-tied. After insertion of both anchors 709 (or barbs), the band 709′is advantageously tightened by hand or by pushing on the knot with aknot-pusher or similar device. Although not shown in FIG. 26, the knotpusher may be integral to the delivery device. After drawing togetherthe tissues surrounding the aperture, inner wall, and outer wall of theannulus, the excess suture line can be cut. It is also possible to use acutting device integral to the delivery device to cut the band aftercinching. Although the device shown in FIG. 26 depicts two anchors beingdelivered from a single device, multiple anchors or barbs could bedelivered from the same or a similar type of device. Additionally, adelivered configuration of fixation means may result from the use of asingle device to deliver multiple anchors sequentially.

The shaft of the device may be of any convenient length, typically from,e.g., 1 inch to 10 inches. Materials of which to make the deliverydevice include, but are not limited to: metals, such as stainless steel,nickel, titanium alloy, and titanium; plastics, such as PTFE,polypropylene, PEEK, polyethylene, and polyurethane, acrylic,polycarbonate, engineering plastics; and/or composites.

Advantageously, the shaft of the device will have a cross-sectionalshape suitable to accommodate an ejection rod and at least one fixationelement, or portion thereof. In one embodiment, at least a portion ofthe shaft of the device may be hollow, having a circular, elliptical,triangular, trapezoidal or other suitable cross-sectional areasufficient to accommodate an ejection rod.

The delivery device may also contain a handle or raised surfaceconfigured to accommodate the shape of surgeon's hands or fingers foreasier handling. Such raised or configured portion may be made of thesame or different material as the tube or shaft. Suitable materialsknown in the art include, among others, polymers, such as acrylicpolymers, polyurethane, polycarbonate, engineering plastics; and metals,such as stainless steel and titanium.

Much of the previous discussion relates to the use of a patch (or stent)for annular repair and/or reconstruction. In some clinical instances,the method of the invention may be accomplished without the use of apatch, however. For example, a patch may be unnecessary to repair smallapertures or apertures of certain shapes, or certain weakened or thinportion(s) of an annulus. The invention therefore also encompassesmethods for repairing or reconstructing annular tissue that do notnecessarily involve the use of a patch, and to fixation devices andtools useful in carrying out these methods, as exemplified in FIG. 25.Accordingly, an additional embodiment of the invention also providesfixation devices that may be used to reapproximate and hold annulartissue. Such fixation devices, as described herein, may contain ananchor portion and a band portion. The anchor portion serves to fix thefixation device in the annular tissue. The band portion, attached to theanchor portion, serves to draw together annular tissue when tightenedand secured. At least one fixation device is placed into, or through,the wall of an annulus surrounding an aperture, weakened, or thinportion of the annulus. The device is then drawn in tension to pulltogether, wholly or partially, the surrounding annular tissue.

The band and the barbs may be separate elements or comprise onecontinuous element. Bands and barbs may be made of the same or differentmaterials.

The bands may be string-like, made from suture or similar material, orof any construction or dimension that is amenable to the delivery andengagement of the fixation device. For example, the band may have awidth greater than, in some embodiments far greater than, its thickness.The suture material may in some embodiments have a width:height ratio of1.25:1. In some embodiments, bands may be constructed, wholly orpartially, of a mesh tube. Moreover, different segments along the lengthof the band may have different dimensions and constructions. Forexample, the band may be constructed of thin material, such as nickeltitanium alloy or stainless steel wire, close to the anchor barbs, whilethe middle portion that spans the aperture may comprise a much widerband made of optionally softer material.

FIGS. 21, 22, and 23 show additional examples of embodiments of theinvention for repair or reconstruction of the annulus that could beutilized without the additional use of a patch. For instance, in FIGS.21A-21C, in lieu of (or optionally in addition to) a patch, two anchorsare shown having passed through the annulus to the subannular space. Bydrawing on band 910, the inner and outer walls of the annulus may bedrawn together in tension, and may also reapproximate the tissuesurrounding the aperture. FIG. 57C shows a single anchor band beingplaced along an incision or tear in the annulus.

The fixation devices of the invention could be delivered as a pair ofbarbs attached by a single band, or each barb could be deliveredindividually Alternatively, multiple barbs (anchors) may be pre-attachedto a single or multiple bands for ease and speed of delivery. Forexample, FIG. 23 shows a fixation device that has multiple anchors 916(or barbs, not shown) connected together in a configuration similar toFIGS. 22B and 22C, with each anchor 916 being delivered individuallyinto, or through the nucleus or annulus. The anchors, if present, may beshown as in FIG. 23. By drawing on the cinch line, the tissuessurrounding the aperture and/or the inner wall of the annulus and/or theouter wall of the annulus are drawn together. Although a knot 914 isshown to affix the suture lines together, other means to lock, fastenclip, retain, or secure the sutures together may also be used.

An additional exemplary depiction of fixation devices that may be usedto reapproximate and hold annular tissue as previously described inFIGS. 21-23 can be seen, for example, in FIG. 78. In FIG. 78, an anchorband assembly 308 and its complementary delivery tool 400, asexemplarily depicted in FIG. 42 and FIGS. 47-56, are used to repair adamaged, degenerated, weakened, or thin portion in an intervertebraldisc annulus having, for example, a circumferential tear 216compromising the integrity of the annulus. Anchor band assembly 308 maydraw in tension the annular tissue surrounding the tear or delaminationof the annular laminae, helping to fortify, reconstruct, augment,repair, or otherwise reinforce the annular tissue.

A further exemplary embodiment of the invention in the form of a braidedpatch 1100 such as depicted in FIGS. 24-32, is a further illustrativeembodiment of the present invention that can be deployed into thesubannular space to act as a barrier to the extrusion of the nucleuspulposus, or other intradiscal material.

The “patch” 1100 is constructed from a braided tube of filaments 1102.The ends 1104 of the braided tube are heat-sealed to keep the braid fromunraveling and the seals also provide structural integrity to the patchwhen deployed. Although the devices described herein principally utilizeheat sealing for forming the ends of the device, there may be a varietyof ways to fixate, secure or otherwise form the ends of the devicethrough the addition of other materials to add structure to thefilaments, to include, but not limited to, the addition of collars orsleeves, dipping the ends in a material to fixate (i.e., heated polymer,adhesive). These added materials could be metallic or polymeric.

The braided patch 1100 is woven on a braiding machine with multiplefilaments 1102 to create the structure. For example, the patch can bewoven with 72 polyester filaments in order to create the construct thatreadily deploys into the annular defect, promotes tissue or matrixingrowth into the device, and retains an anchor after it has been placedthrough the wall of the annulus and through the patch. Changing thenumber of filaments 1102 in the patch, the material of the filaments,the dimension of the filaments (e.g., diameter), as well as theconfiguration of the filaments (e.g., cross-sectional area), or changingthe braid pattern, can create differences in the characteristics of thepatch. The braided patch can be made on a standard Steeger braider, orsimilar type braiding machine, that can handle braiding from anywherefrom 16 filaments at a time, to up to 196 filaments. Preferably thepatch is braided with between 32 to 144 filaments. In one exemplaryembodiment of the present invention, the device is braided with 72filaments of polyester filaments, with every other braid filament beingapproximately 0.012″ diameter, alternating with yarn (e.g.,approximately 64 microfilaments, each approximately 17 microns indiameter, bundled) or alternating with a polyester braid monofilamentapproximately 0.004″ in diameter.

In addition, much of the description herein depicts devices thatgenerally have a tubular form, although it is also anticipated thatthese devices could be woven on the braider (i.e., by changing theconfiguration of the braiding mandrel), or reformed in processing (i.e.,heat forming) to obtain a patch construct that deviates from a“circular” cross section, in order to obtain different characteristicsof the patch pre, during or post deployment to accommodate anatomical,physical, and biological considerations of the patient or the deliveryof the implant. These device configurations may include square,rectangular, oblong, symmetrical, non-symmetrical, triangular, “cloverleaf”, or other cross-sectional constructions that may be partially(i.e., only in a portion of the device body, and/or only in a portion ofthe device ends), or completely present throughout the device.

The filaments 1102 of the patch can be made of different materials ordimensions, or all of the filaments in a patch can be of like materialand dimensions. The filaments can be biocompatible metallic material,such as a stainless steel, a nickel titanium alloy, or other metallicmaterials. The patch 1100 can also be made from biocompatible polymericmaterial such as polyethyleneteraphthalate (PET), polyester,polyethylene, polycarbonate urethane, polymethylmethacrylate, orpolypropylene, for example. It is also conceivable that the patch can bebraided from biodegradable materials, such as polyglycolic acid (PGA),polylactic acid (PLA), collagen (or its derivatives), fibrin (or itsderivatives), cellulose (or its derivatives), polysaccharides (or itsderivatives) or other biocompatible material that may degrade and/or bere-absorbed by the body over time.

It is also possible to braid the patch 1100 with multiple materialsand/or multiple dimensions of the filaments. For example, the patch canbe braided with 32 filaments of a polymeric PET material and 32filaments of polyester yarn material to create a patch that may beoptimal for sealing an annulus. The combination of different filamentmaterials, sizes, cross-sectional configuration, number of filaments,and braiding pattern can be used to construct a braided patch that canbe delivered into the sub-annular space, while acting as a scaffold toinduce healing of the aperture.

The braided patch has advantages in that it can be placed through anaperture in the wall of the annulus that is relatively small, but thenexpand to a dimension that is substantially greater than the aperture.For example, it is possible to construct the braided tube to be lessthan 5 mm in diameter, whereas in its fully deployed state it could begreater than, for example, 20 mm. This is exemplary and is not intendedto be construed as limiting in the actual dimensions of the device preand post deployment.

Referring to FIG. 28, the non-deployed braided patch 1100 is affixed onthe distal end of the patch delivery tool 1200. It is situated in afashion that is co-axial 1208 with the delivery tool's delivery members,which include inner delivery member 1202. A finger grip 1206 can beformed onto the proximal end of the delivery tool body to assist inmanipulation. Further detail of the deployment mechanism can be seen inFIG. 29. The braided patch 1100 is placed on the distal end of the innerdelivery member 1202. The heat-set distal cuff 1104 of the patch issituated within a depressed region on the distal region of the innerdelivery member 1216. The distal portion of the delivery member 1216 isslotted as shown in FIG. 31, and, in the non-deployed state, contains aco-axial retention member 1208 that acts to press the slotted portionsof the inner delivery member apart, and thus securing the distal cuff ofthe patch 1104 on the distal region of the inner delivery member 1202.The proximal portion of the patch abuts and is in contact with an outerpusher member 1204. In the non-deployed state, the delivery device ispassed into the aperture of the annulus. Once inside the annularaperture, the outer pusher member 1204 of the delivery device 1200 ispushed toward the distal end of the device, while the inner deliverymember 1202 is pulled proximally. This action of moving these members insuch a fashion results in the braided patch expanding perpendicular totube's axis, as shown in FIGS. 27 and 30.

Once the patch 1100 has been expanded to its fully expanded state, acinch line 1212 that is connected to the distal and proximal ends of thepatch can be tightened and a knot, such as a Roeder knot, can be used tohold the braided patch in its expanded configuration. Although, thedevice is shown with a cinch knot 1214, it is possible that a lockingelement may not be needed, depending on the means used to fixate thepatch into the annulus. It is possible that no locking means isnecessary. It is also possible that alternative locking means can becontemplated to keep the braided patch in its expanded form. A knotpusher 1210 can also be employed to manipulate the knot locking device1214.

Once the device patch has been expanded into its final configuration inthe aperture and subannular space, the retention member 1208 can beremoved from the distal portion of the inner member by slidably pullingthe proximal end of the retention member in a proximal direction.Removing the retention member relieves the stress holding the distalcuff of the patch in place and allows the patch to be slidably removedfrom the distal end of the delivery device, and thus deployed into thesubannular space.

As depicted in FIG. 32, the patch 1100 can be affixed to the innersurface either before or after the deployment of the patch from thedelivery device. It is also contemplated that this patch can be affixedto the inner surface of the annulus by the various fixation meansdescribed in other parts of this application. For example, anchor bandsas shown in FIG. 32 could be used to penetrate the annulus 1306, shownbetween vertebrae 1302, and the patch to anchor the patch into thesub-annular space. It is also conceivable that single T-anchors 1310with a band 1314 (e.g., suture) could be delivered through the annulus1306 and patch 1100 with the portion of the suture on the outer surfaceof the annulus locked to the outer surface with a knot, pledget, orother locking device 1316. Path 1312 illustrates another possible suturepath through the bone of the vertebra to penetrate and hold a T-anchormember 1310 in the patch. It is also conceivable that the patch could beaffixed to the inner surface of the annulus through the use ofadhesives, such as cyanoacrylate, fibrin glue, polymer protein,polyurethane, compounds that mimic mussel shell adhesive proteins(manufactured by Nerites Corp.), adhesive materials that may be used asadhesives for dural or dermal wound repairs/sealing, or other materialused to cure, or adhesively affix the patch in the subannular space insitu. The delivery of these adhesive fixation materials could bedelivered through the patch delivery tool, as depicted in FIG. 76 orthrough the anchor band delivery tool, FIG. 77, or both. FIGS. 76 and 77are illustratively intended to depict an alternative embodiment (furtherdescribed below) of the invention in which a nuclear replacementmaterial 218 may be delivered to the intervertebral disc, although theymay also exemplify methods and devices to delivery adhesive materials.It is also contemplated that if an adhesive were used to affix the patchto the annulus that an additional membrane material may be added to thepatch device to further help restrict fluidic extravasation of thematerial out of the disc during adhesive delivery, if required.Conversely, the patch construction may be altered to reduce the patchporosity in order to accomplish a similar objective. Furthermore, it isanticipated that materials maybe added to, or changed, on portions thedelivery tools to reduce the possibility of the tools being adhesivelybonded to the instruments during delivery. For example, cannula 526 inFIG. 76 may be coated with, or be constructed of, PTFE, FEP,polypropylene, polyethylene or other lubriocious materials or coatings.Similarly, portions of delivery device 400 in FIG. 77 may have similarmaterial treatments to accomplish the same objective.

The advantages of the braided design, given the right selection offilament dimension, configuration, material, braid pattern, and numberof filaments is that it can be easily delivered to the annular repairsite, have the flexibility to take the shape of the annular defect whilemaintaining the mechanical integrity needed to remain within the discspace upon loading. Another advantage, again with the appropriateselection of material, filament configuration, braiding, dimensionalconsiderations, and multiple filament weaves, is that one can constructa patch that is conducive, in its deployed state, for incorporation offibrosis and the fibrotic healing of the annular defect. Finally, thepatch can be designed so that when it is in its delivered state, it caneasily receive one or more anchor bands through the braided filamentswhile retaining the T-anchor or other similar type fixation device,after passing the fixation device through the patch.

FIGS. 33-41 depict an illustrative method for the deployment of atreatment device into the intervertebral disc 200. As describedpreviously, there are a variety of applications, approaches, techniques,tools, and methods for accessing and performing spinal disc surgerywhich may be dependent on physician preferences and could be arbitrary.Therefore, the following description and depiction of the method shouldbe considered illustrative and not limiting. In the illustrativescenario which is used in the following descriptions, and with referenceto FIG. 33, the disc 200, which is comprised of the annulus fibrosus 202and the nucleus pulposus 204, is shown in a transverse cross section.The disc 200, as described above, is disposed anatomically betweencaudal and cephalad vertebral bodies, which a portion of a vertebralbody (spinous process 206) seen in FIG. 30. The disc 200 may be accessedfor treatment via a surgical incision 208 made in the paramedian regionlateral of the spinal canal 210. A microdiscectomy procedure may precedethe placement of a treatment device in order to remove disc fragmentsand to provide a subannular cavity 212. The subannular cavity 212,however, may be preexisting or may be created for the purpose ofperforming a nuclear augmentation An aperture 214 in the annulusprovides a path for the mesh or treatment device delivery tool 500 toplace treatment device 600. The treatment device 600 can take the formas described in the embodiments above, or as additionally describedbelow with reference to FIGS. 63-64, as described in commonly-assignedcopending U.S. patent application Ser. No. 10/352,981, filed on Jan. 29,2003 and incorporated herein by reference, or any other appropriateform. Likewise, the anchor band delivery device 400 can take the form asdescribed in the embodiments above, or as additionally described belowwith reference to FIGS. 47-52, as described in commonly-assignedcopending U.S. patent application Ser. No. 10/327,106, filed on Dec. 24,2002 and incorporated herein by reference or any other appropriate form.

As shown in FIG. 33, a delivery device 500 is introduced throughsurgical incision 208 to traverse aperture 214 and position treatmentdevice 600 in subannular cavity 212. As depicted, treatment device 600is in a first configuration sized to permit its passage to thesubannular cavity 212. FIG. 39 shows a detail, sagittal view of meshdevice 600 mounted on the distal portion 602 of delivery tool 500,introduced to the cavity. Also shown are sections of intervertebral disctissues. As illustrated, treatment device 600 may have element 608 tolatch the mesh device once deployed into its final deployedconfiguration. If required, there may be a variety of ways to latch,lock or otherwise secure the device in its final configuration, asdescribed previously, or additionally depicted and described below inFIGS. 71A-E below.

As depicted in FIG. 34, the treatment device delivery tool 500 can bemanipulated by, for example, pulling a finger grip 502 in the directionof arrow 300 to deploy treatment device 600 in the subannular cavity212. As illustrated here, this deployment involves a longitudinalshortening of the treatment device, drawing end 606 toward end 604,resulting in a lateral expansion of the treatment device 600. Thepulling of the finger grip 502 may be preceded by the release of asafety lock 504 preventing deployment of the treatment device untilintended by the surgeon. As illustrated here, the lock is releasedthrough rotation of handle member 504 in the direction of arrow 302.Also shown is a marking 538 on the delivery tool 500 that may visuallyassist the surgeon in assessing the degree to which the device has beenplaced in subannular space.

FIG. 35 shows the finger grip 502 reaching its intended limit, and theconcomitant full intended deployment of treatment device 600, where end606 reaches its intended design position for the deployed configurationof the device 600. In this illustrative depiction, end 606 is pulledadjacent to end 604, and device 600 has reached its maximum intendedlateral expansion. As shown, the deployed device 600 may be pulled tointernally engage and at least partially conform to the cavity 212.Naturally, the full travel of the finger grip 502 can be determined bythe design of the delivery device, or informed by the judgment of thesurgeon through visualization, tactile realization, or the like. Oncethe intended limit has been achieved and the device fully deployed, thedelivery device 500 can lock finger pull 502 in place so as to maintainthe treatment device 600 in the deployed configuration. It may also beadvantageous for the delivery tool 500 to have a perceptible (i.e.,audible, tactile, visual) indication that the treatment device has beenfully deployed. The mesh/patch delivery tool 500 may be of the typedescribed hereinabove, or as additionally described in FIGS. 57-62below, or in other sections of this disclosure.

FIG. 36 next depicts a fixation element or anchor band delivery device400 introduced through surgical incision 208, where the distal end 402is passed through the annulus fibrosus 202 adjacent to the aperture 214,and subsequently through treatment device 600, as illustrated by arrow190. Fixation element delivery tool 400 may have features to providetactile feedback once the delivery tool has been introduced into tissueto an acceptable extent, for example a feature like tissue-stop 432. Asillustrated, delivery device 400 is passed distally until stop 432 andpledget member 309 of the fixation device 308 come in contact with theouter surface of the annulus. Alternatively, and without tissue stop 432use, pledget member 309 could be of construction to similarly resist, orotherwise visually or tactilely indicate ceasing the passage of deliverydevice 400 through annular tissue. FIG. 44 shows a detail, sagittal viewof a distal end of a fixation element delivery tool 400 introduced intodisc tissue and through treatment patch 600. As shown in FIG. 44, onefixation element has been deployed and fixated. FIG. 44 also depicts anexemplary treatment device detection feature 442 on the outer surface ofneedle cannula 428, as more clearly illustrated in FIG. 48. The patchdetection feature 442 on the distal end of needle cannula 428 mayadvantageously provide perceptible feedback (tactile and/or audible) tothe surgeon that the anchor band delivery tool has accessed andpenetrated the patch and it is therefore acceptable to deliver the band.Feature 442 is discussed in more detail below. In operation asillustrated in FIG. 36 and in FIG. 37, the delivery device 400 can bemanipulated similarly to the treatment device delivery tool. Forexample, moving finger grip 404 in the direction of arrow 304 willwithdraw a portion (for example, the slotted needle cannula 428) ofdistal end 402 of the device 400 and deploy a fixation element 308, asmore described below, in the subannular cavity 212 to secure thetreatment device 600. The pulling of the finger grip 404 may be precededby the release of a safety lock 406 preventing deployment of thefixation element until intended by the surgeon. As illustrated here, thesafety 406 is released through rotation of safety 406 in the directionof arrow 306. The fixation element delivery tool 400 may be of the typedescribed hereinabove, or as additionally described in FIGS. 47-56below, or in other areas of this disclosure.

FIG. 37 depicts the deployment of a fixation element, 308 into disctissue following the deployment of FIG. 36. The fixation device may beas described above, for instance a T-anchor, suture, tether, knot,pledget or barb. As illustrated here, the fixation element 308 is aT-anchor with suture bodies, knot, and pledget as more fully describedbelow. During the pulling of finger grip 404 and retraction of slottedneedle cannula 428, a knot pusher end 406 of inner cannula 426 is shownholding a proximal portion of the fixation device's 308 slip knot 440,while T-anchor 316 is drawn in tension proximally by tether or sutureline 310, to adjust the length of the fixation element 308 to providethe proper tension to securely hold the treatment device 600 in situ. Aproximal end of the fixation element, such as a pledget 309, is held orurged into engagement with a bearing surface on the exterior of theannulus. The proximal end of the fixation device can also include aT-anchor or knot or similar tissue locking element. FIG. 48 is a crosssectional view of the distal end of delivery tool 400 as it may beintroduced in disc tissue. FIG. 55 shows the distal end of the deliverytool 400 after retraction of the slotted needle cannula 428 andtensioning and drawing T-anchor 316 proximally to a potential finalstate. The proximal drawing of T-anchor 316 is also illustrated in adetail, sagittal view in FIG. 45, with arrows 324 illustrating motion ofthe T-anchor. The construction of the locking element 316 is exemplaryand is not intended to be limiting of alternative constructions of 316,such as one or more pledgets, knots, barbs or other forms to effect thesame function.

FIG. 38 shows the partial withdrawal of the fixation element deliverydevice once the fixation element has been deployed. In the illustrationsshown, the final step during the pulling of finger grip 404 proximallyresults in the release of the fixation element in situ. The release maybe accompanied by visual or tactile or auditory confirmation, such as aclick. Once released, the fixation element delivery tool can becompletely withdrawn as shown in FIG. 39, leaving the suture body 310 ofa fixation element extending through the surgical incision 208. Theproximal portion of suture body 310 may be cut to a suitable length withreadily available surgical tools such as a scalpel or surgical scissorsand removed from the surgical site. FIG. 43 shows a detail, sagittalview of a single deployed anchor band assembly 308 with T-anchor 316,pledget 309, slip knot 440 and associated tether components 318 and 310(after it has been cut in the epi-annular space). Also shown areportions or sections of intervertebral disc tissues. As shown, fixationelement 308 is fixedly engaged with the disc tissue and the patch 600.FIG. 40 depicts the treatment device 600 after placement of 2 fixationdevices 308, as does FIG. 46 shown in a detail, sagittal view Of course,any number of fixation devices appropriate to secure the treatmentdevice 600 can be used. It is also anticipated that device 600 may be ofa construction and design, as described herein, that does notnecessitate anchor bands to effect securement of device 600 within thedisc space and therefore, illustrations using fixation elements are tobe exemplary, and not limiting. Once secured, the treatment device 600is released from the delivery tool 500. As illustrated here, this isaccomplished in a two-step process. First the release mechanism isenabled by rotating knob 506 in the direction of arrows 312. Anindicator may then be activated as shown by arrow 320 of indicator 508in FIG. 41, such as spring-loaded release indicator 508 to notify thesurgeon that the treatment device has been released from the deliverytool 500. Accompanying the deployment of indicator 508 is the uncouplingof the treatment device 600 at the distal end 602, as will be describedin greater detail below. The delivery tool 500 can then be withdrawn asdepicted in the transverse view of FIG. 41, leaving treatment device 600in situ.

FIGS. 47-53 depict illustrative embodiments of an fixation elementdelivery tool (or FEDT) as discussed above, which may be referred toalternatively as an anchor band delivery tool (or ABDT). The fixationelement 308 is depicted as loaded in the distal end 402 of the ABDT,which will be discussed in greater detail with reference to FIG. 48. TheABDT 400 is comprised of a main body member 410 which may be fixedlyattached distally to outer cannula 422, and also to inner cannula 426 atinner cannula anchor 438. Distally, inner cannula 426, as betterillustrated in detail in FIG. 48, may comprise a knot pusher (or othermeans to effect securement of suture tethers 310 and 318 with lockingelement 440) and T-anchor stand-off 434. Proximally, main body 410 hasdisposed safety member 406 with an outside diameter telescopically androtatably received in the inner diameter of a knob 408. Knob 408 andmain body member 410 are rigidly attached to one another Slidablydisposed within the lumen of the main body member 410 is sutureretention block 414, depicted with suture body 310 threaded through itscenter hole. A spring 316 is also slidably disposed within the lumen ofthe main body member and can abut either suture retention block 414 orslider member 418. Slider member 418 can be integral with finger grip404 (not shown) as depicted in FIGS. 36-38. Attached to the proximal endof slider member 418 is a suture cutting blade assembly 420. The bladeassembly, as will be discussed in greater detail below, serves to severthe suture body after deployment of the fixation elements as describedherein. A slot in the slider member 418 allows the slider member 418 toslide past the outer cannula anchor 426 and, as described previously,426 may be stationary with respect to main body 410. A slotted needlecannula 428, slidably disposed in the lumen of the outer cannula 422, issecured the distal end of slider member 418 by needle cannula anchor430, such that the translation of the slider member 418 within main bodymember 410 concomitantly translates the slotted hypotube 428 within theouter cannula 422.

FIG. 48 is a detailed view of the distal end 402 of the ABDT 400. Asdescribed above, the slotted hypotube 428 is slidably received in theouter cannula 422. A tether, consisting of a suture line 318 and apledget body 309 is located in proximity to an optional tissue stop 432on the outer cannula 422. It is also possible for pledget 309 to be heldby an optional outer cannula pledget holder 433 until release of theanchor band. The suture line 318 is slidably knotted to suture body 310.The distal end of suture body 310 is attached to T-anchor 316, which isheld by T-anchor stand-off 434. As described above, T-anchor stand-off434 and knot pusher 436 may be components of inner cannula 426. In theinitial configuration, needle hypotube 428 extends distally of outercannula 422 and allows the point of slotted hypotube 428 to extenddistally of the T-anchor holder 434.

FIGS. 47 and 48 depict the ABDT in its initial delivery configuration.The ABDT is locked in this configuration by the distal end of safety 406engaging the finger grip 404 (not shown) as depicted in FIGS. 36-38.Turning now to FIG. 36, the rotation of handle member 406 in thedirection of arrow 306 allows the finger grip 404 (not shown) to engagea slot on safety 406, and permits the surgeon to pull finger grip 404proximally toward the proximal knob 408. Doing so results in thetranslation of the slider member 418 proximally, and concomitantly, theproximal translation of the slotted needle cannula 426 (as a result ofslotted needle cannula anchor 430) in the direction of arrow 326(illustrated in FIG. 45). The result, as discussed above, is theunsheathing by the needle 428 of T-anchor 316 held by T-anchor holder434. The translation of the slide body 418 proximally also urges thespring 416 and suture retention block 414 proximally. The sutureretention block 414 is attached to suture body 310, and thereforetension is leveraged onto the suture body 310 to hold it taught and,when appropriate, draw T-anchor 316 from within the delivery tool to aposition proximally.

FIGS. 50 and 51 illustrate the partial deployment of anchor bandassembly from ABDT, wherein slotted needle cannula 428 has beenpartially retracted to expose T-anchor 316. FIG. 49 is a detail, crosssectional view of the distal end of the handle of ABDT 400,illustratively showing the inter-relationships of delivery toolcomponents in the initial configuration and FIG. 52 is a similar detail,cross sectional view showing the inter-relationships after at least apartial deployment of device 400. FIG. 53 is a detail of the sutureretention body 414, suture body 310, spring 316 and cutting assemblyblade 420, during partial deployment of delivery tool 400, as discussedabove.

As depicted in FIG. 54 and detail drawings of FIGS. 55 and 56, as sliderbody 418 continues to slide proximally, in addition to continuing todraw T-anchor as shown in FIG. 55 with arrows, the tether retentionblock 414 reaches the limit of it's proximal translation (discussedfurther below), and the slider member engages and compresses spring 316.As the spring is compressed, the blade assembly 420, which is alignedwith the hole of suture retention body 414 through which suture body 310passes, comes into engagement with the suture body 310. FIG. 56 is adetail view of the blade 420 severing the suture body 310. Up to thelimit of travel of the suture block 414 and the severing of tether 310,the suture body 310 continues to apply tension to the T-anchor, as shownin greater detail in FIG. 55. With knot pusher holding knot 440, pledget309, and suture 318 in apposition, and in distally exerted fashion, tothe tensioning of suture body 310, anchor band assembly 308 isadvantageously cinched into a fixing and/or compressive relationshipbetween ends 309 and 316, as well as any structures (e.g., nucleus,annulus, treatment device) between elements 309 and 316. After severingsuture body 310, suture body 310 is still attached, to the anchor band,but has at this point been severed proximally. The suture body 310 willtherefore be unthreaded from the interior of the ABDT as the ABDT iswithdrawn. As discussed above the suture line 310 may be further cut tolength with readily available surgical scissors. Alternatively, asevering mechanism similar to those described herein in the distalportion of tool 400 may be employed to avoid an additional step oftrimming the end of body 310.

FIG. 53 is a detail of the suture retention body 414, suture body 310,spring 316 and cutting assembly blade 420, during partial deployment ofdelivery tool 400, as discussed above.

Additionally inventive of the anchor band device (and its delivery anddeployment tools) is the unique inter-relationship of the slide body,spring, and the tension delivered to the T-anchor and tissue duringdeployment. For example, T-anchor assembly can be designed to passthrough softer, or otherwise more pliable tissues (e.g., nucleuspulposus, softer annular layers) while resisting, under the sametension, passage through tougher tissues and/or substrates (e.g., outerannular layers, treatment device construct). In further illustrativedescription, tension delivered to the suture line 310 can be limited bythe interface between the slide body member 318 and the suture retentionblock 414, through spring 316 such that tension is exerted on T-anchorbody 316 which may sufficiently allow movement of T-anchor 316 throughsofter tissue, but alternatively requires a greater force to pullT-anchor body through other materials or substrates such as thetreatment device 600 or outer layers of the annulus 202. Spring 316 canbe designed to sufficiently draw tissues and/or the patch together,while not overloading suture line 310 when the fixation has beeneffected. Spring 316 may also be advantageously designed to allow bladeassembly 420, upon reaching an appropriate loading to effect thedelivery, to sever the suture line 310. As illustrative example, but notintended to be limiting, T-anchor body and suture line may beconstructed to require approximately 5 pounds of force to draw theT-anchor assembly through nuclear tissue, but substantially greater loadto draw T-anchor through annular tissue and/or patch device. Spring maybe designed to exert approximately 5 pounds, sufficiently pulling anchorthrough nuclear tissue, and in proximity to treatment device, asintended. Once sufficient load has been applied to move T-anchor toengage patch, the loading on the suture line is not allowed tosubstantially increase. Advantageously, additional loading would causethe final compression of spring between suture retention block and bladeassembly to sever suture line. Preferably, the severing and the designof the tether elements are such that the ultimate strength of the sutureline is greater than the load required to draw T-anchor through softtissue, or the like, and less than the load inflicted to cause thesevering by blade assembly. The description herein is intended to beillustrative and not limiting, in that other device and delivery toolscould be derived to employ the inventive embodiments.

FIGS. 57-62 depict illustrative embodiments of a therapeutic devicedelivery tool (TDDT), or mesh delivery tool (or MDT) as discussed above.The treatment device (or mesh or patch) 600 is depicted as loaded in thedistal end of the TDDT 500, which will be discussed in greater detailwith reference to FIG. 58. The TDDT 500 is comprised of a main bodyhousing 510 which may be fixedly attached distally to outer cannula 522,which in a lumen thereof slidably receives a holding tube assembly 526.Distally, holding tube 526, as better illustrated in detail in FIG. 58,may comprise a slotted end and accommodate an actuator rod or stylet 514in an inner lumen. Proximally, main body 510 has disposed thereon safetymember 504, and has an outside diameter telescopically and rotatablyreceived in the inner diameter of cap 506. Cap 506 forms part of end capassembly 524, which also comprises ball plunger assembly 536, which willbe described in greater detail below. Slidably disposed within the lumenof the main body member 510 is actuator body assembly 518, which abutsat its distal end, optionally in mating fashion or via detents, againsta proximal end of finger grip member 502, which his also slidablydisposed in the lumen of main body 510. At the proximal end of theactuator body assembly 518 is formed device release indicator 508, whichwill be described in greater detail below. A spring 516 is also slidablydisposed within the lumen of the main body member and can abut eitheractuator body assembly 518 or finger grip member 502. The finger gripmember can optionally comprise finger members at a distal end, carryingdetents to engage with tabs, slots, or other cooperative structure onthe inner lumen of main body 510 to lock the finger grip member,aggressively or gently, in the undeployed (unused) or deployed (used)configuration. A holding tube assembly, in the form of a slottedhypotube needle cannula 526, is slidably disposed in the lumen of theouter cannula 522, and is secured to the distal end of actuator bodyassembly 518, such that the translation of the finger grip member 502proximally within main body member 510 concomitantly translates theactuator body assembly 518, and thus holding tube assembly 526 withinthe outer cannula 522.

FIG. 58 is a detailed view of the distal end 602 of the TDDT 500. Asdescribed above, the holding tube assembly 526 is slidably received inthe outer cannula 522. The TDDT is designed to releasably deploy thetreatment device 600 after the distal end 602 is navigated by thesurgeon to the intended deployment site. The treatment device 600, shownin cross section and discussed further below, comprises a proximal end,forming a collar or cuff 604, and a distal end, also forming a collar orcuff 606. The proximal end 604 is slidably disposed on holding tubeassembly 526, and abuts and is held stationary by outer cannula 522. Thedistal end of the holding tube assembly 526 can be formed to carrytreatment device latch 608. The device latch 608 is formed with a flangeor other detent to engage the distal end of treatment device 600,preferable the distal most end of distal collar 606. The slotted end ofholding tube assembly 526 is held radially rigid by actuation rod 514,such that the treatment device 600 is held firmly on the distal end 602of the TDDT 500.

FIGS. 57 and 58 depict the TDDT in its initial delivery configuration.The TDDT is locked in this configuration by the distal end of safety 506engaging the finger grip 502. Turning now to FIG. 59, the rotation ofsafety 506 in the direction of arrow 302 allows the finger grip 502 toengage a slot on safety 506, and permits the surgeon to pull finger grip502 proximally in the direction of arrow 300 toward the proximal cap506. Doing so results in the translation of the slider member 518proximally, and concomitantly, the proximal translation of the holdingtube assembly 526. The result, as further illustrated in FIG. 60, is themovement of the distal end 606 of treatment device 600 moving toward theproximal end 604, resulting in a bulging or lateral expansion of thetreatment device 600. The translation of the actuator body assembly 518proximally also urges the device release indicator 508 proximally, aswill be discussed further below.

FIG. 60 depicts the distal end of the TDDT 500 after fully withdrawingthe finger grip member 502 proximally, as discussed above. When thefinger grip has reached the limit of its intended travel upon beingpulled by a surgeon, the treatment device 600 will be in it's deployedconfiguration. In this configuration, detents on the proximal end oftreatment device latch 608 will be poised to engage the proximal end 604of treatment device 600 to hold it in the deployed state. As illustratedin FIG. 60, the actuation rod 514 can be seen to hold the distal end ofthe holding tube assembly 526 engaged with the distal end 606 of thetreatment device 600, providing for maneuverability or removal untilreleased.

FIGS. 61 and 62 illustrate the final deployment of the treatment device600 just prior to withdrawal of the TDDT. As shown in FIG. 61, therotation of cap 506 in the direction of arrow 312 releases actuator bodyassembly 518 from ball plunger 536, permitting its translationproximally under the bias of spring 516. Translation of the actuatorbody assembly 518 withdraws actuator rod 514 in the proximal direction,which permits the release of the treatment device 600 from the distalend of the TDDT, as further described with reference to FIG. 62. Thetranslation proximally of actuator body assembly 518 permits indicator508 to emerge from a hole in the cap 506, providing a perceptibleindication to the surgeon that the TDDT can be removed and will leavethe treatment device in situ. Turning to FIG. 62, the withdrawal of theactuation rod 514 is illustrated, which allows for inward radialcompression of the tip of the holding tube assembly 526. Once the distalend of the holding tube assembly 526 is compressed radially inwardly, itcan then pass through the inner diameter of the treatment device latch608, and allow withdrawal of the entire TDDT from the treatment device600. The final disengagement of the distal end of the outer cannula 522can advantageously permit the engagement of detents on the treatmentdevice latch 608 to engage the proximal collar 604 of the treatmentdevice 600, locking it in a deployed configuration.

Additionally inventive of the treatment device (and its delivery anddeployment tools) is the unique inter-relationship of the actuator body,spring, and the holder tube assembly, allowing the device to be deployedwhile still holding the device firmly during deployment. The use of theactuator rod to stiffen the distal end of the small diameter outercannula, and the use of a radially compact treatment device offersadditional advantages, such as the ability to pass through softer, orotherwise more pliable tissues (e.g., nucleus pulposus, softer annularlayers) while resisting columnar bending during navigation. As anillustrative embodiment, a mesh patch as described in FIGS. 63 and 64can be employed, but such a device configuration is not intended to belimiting. Other devices that expand radially through linear actuationcan also be used.

The spring may be designed to exert approximately 5 pounds, sufficientto provide tactile control while preventing inadvertent release of thetreatment device. By requiring actuation of the device in a differentdirection for release (i.e., rotation of the proximal cap) than thatrequired for initial deployment (i.e., proximal translation of thefinger grip), each with tactile, auditory or visually perceptibleconfirmation, safe an affirmative deployment can be achieved.

FIGS. 63 and 64 depict anterior views of the distal end 602 of the TDDTand treatment device 600 following deployment. FIG. 63 shows the distalend of holding tube assembly 526 engaging the treatment device latch608. FIG. 64 shows the distal end of 526′ disengaged, followingwithdrawal of the actuation rod 514 as discussed hereinabove.

Additional embodiments of treatment device 600 might includeconstructions that can be “inverted” or “non-inverted” at the either, orboth, ends of the device. As illustratively depicted in FIGS. 66A-66C,device 600 is shown in its deployed state, and FIG. 66C may be exemplaryof devices described previously wherein distal device portion 606 has a“non-inverted” configuration, shown with distal cuffed portion extendingdistally, and away, from the body of device 600. Similarly, FIG. 66Creveals a proximal portion 604 of device 600 extending proximally, andaway, from the body of device 600. Conversely, FIG. 66B illustrativelydemonstrates a proximal portion of device 600 in an “inverted”construction, shown with proximal cuffed portion extending distally, andtowards, the body of device 600. Advantageously, a deployedconfiguration with inverted proximal portion of device depicted in FIG.66 may allow less material of the device to project proximally, in use,and possibly reduce risks of causing injury to elements outside of thedisc, including if a device were to expulse from the disc subannularspace. FIG. 66A depicts a device construction in which both end portionsof the device are “inverted”. Changing constructions on ends of thedevice may also, advantageously, facilitate device 600 deployment and/ordevice function in the repair of an aperture, weakened, or thin portionin the annulus fibrosus.

In alternative embodiment in the construction of device, such as, forexample implant 600, devices may be pre-set in a heat forming process toinduce the device to have different structural or physicalcharacteristics during the introduction, delivery, deployment, fixationor otherwise use of the device to treat a treatment site. Anillustrative example of a pre-set heat forming process is shown in FIG.67 wherein device 600 is shown in cross section through a longitudinalaxis. As shown, device 600 is folded along four axial dimensions in itsundeployed state A configuration, such as shown, could, for example,advantageously reduce the radial profile of the device in order tofacilitate introduction into the subannular cavity or provide otherbenefits in the functioning of the device and its delivery. Such abenefit is illustrative, is not intended to limit the many otherbeneficial effects of altering configurations of devices, or theircomponents as described herein. After deforming the device into adesired configuration, the device may be held in a mold or similarretention apparatus and subjected to a heating process to “heat-set” thematerial of the device. Naturally, temperature and time duration ofheat-setting process are dependent on a device's (and/or components of adevice) materials. As an example, but not intending to limit the scopeof the invention, if device were comprised of polyethyleneteraphalate(PET) the heat-set process might be accomplished in a temperature rangeabove the material's glass transition temperature (typical glasstransition temperatures of various PET's range from approximately 160degrees Fahrenheit to approximately 180 degrees Fahrenheit) and belowthe material's melting temperature (typical melting temperatures ofvarious PET's range from approximately 450 degrees Fahrenheit toapproximately 550 degrees Fahrenheit)). One skilled in the art wouldrealize that this process is illustrative and will vary depending on thematerial and the intended characteristics of the device., and thereforeshould not be limiting in the scope of the invention.

Although FIG. 66A exemplifies a device that is folded along the axis infour equidistant creases, it is clear that the device could beconstructed with a single fold or multiple folds, and that four folds isonly an example. It is also possible that a single fold or more could belocated in a fashion that does not result in a geometrically spacedfolds along the axis, for example, a device might have two folds locatedon generally one side of the device. In addition, it is also possiblethat one might beneficially construct a configuration in which only aportion of the device has a fold along its longitudinal axis. Further,it is also possible to obtain alternative characteristics of the deviceby creating one or more circumferential folds (partially, or wholly)along longitudinal axis of a device. It is also possible that the devicemay have a combination of axial, radial, or otherwise special heat setfolds or configurations to beneficially affect the characteristics ofthe implant.

In additional alternative embodiments, it may be possible to performalternative processes on the implant that may alter the structural orphysical characteristics of the device, advantageously inducing thedevice to evince beneficial characteristics during the introduction,delivery, deployment, fixation or otherwise use of the device to treat atreatment site. For example, it is possible to provide heat to selectedregions of a device to heat melt, heat seal, or otherwise flow and/orfixate various components of a device in selected regions, thus causingthe device to have different characteristics during the pre-deployment,deployment or post-deployment of the device. Inclusive in the inventiveembodiments are elements that are fixedly attached to at least anelement of a device to also effect beneficial characteristic changes ofan otherwise unaltered device. The elements may, or may not be ofsimilar materials as the treatment device. FIG. 68A shows a side view ofdevice 600 with a single rib 640 of material affixed to the device, orconversely a rib 640 created by heat setting the material of the device.It should be understood in the description and depictions herein thatthe rib 640 can be constructed of either form, and the descriptions isintended to be illustrative and not limiting. FIG. 68A exemplifies asingle rib 640 element placed along the longitudinal axis of a device600 having end portions 604 and 606. FIG. 68B shows an expandedconfiguration of device 600 of FIG. 68A as seen from the proximalportion 604 of device 600. As can be seen, the rib 640 mayadvantageously change the configuration of a device to induce the deviceto have different structural or physical characteristics during theintroduction, delivery, deployment, fixation or otherwise use of thedevice to treat a treatment site. Applying heat sealing to a treatmentdevice may be accomplished by a process similar to heat setting,although the temperatures and duration of time of the process would mostlikely differ. Naturally, temperature and time duration of heat-sealingprocesses are dependent on a device's (and/or components of a device)materials. As an example, but not intending to limit the scope of theinvention, if device were comprised of polyethyleneteraphalate (PET) theheat-seal process might be accomplished in a temperature range slightlybelow, equal to, or above the material's melting temperature (typicalmelting temperatures of various PET's range from approximately 450degrees Fahrenheit to approximately 550 degrees Fahrenheit). One skilledin the art would realize that this process is illustrative and will varydepending on the material and the intended characteristics of thedevice., and therefore should not be limiting in the scope of theinvention. There are a variety of methods that may be used to applyheat-sealing processes, welding, or otherwise melting the material of adevice, such as laser, heat iron, RF, and ultrasound. Although FIG. 68shows as single rib along the device, it is anticipated that the devicecould have any combination of radial, axial, or otherwise special ribsor rib configurations to beneficially affect the characteristics of theimplant, as are further illustrated in FIGS. 69A-D. FIGS. 69A, 69C, 69C,69D illustrate multiple ribs on device 600. FIG. 69A illustrates ribsaligned a longitudinal dimension of the device. FIG. 69B is exemplary ofa circumferential rib, with 69C illustrating partially applied ribs in acircumferential fashion. FIG. 69D is illustrative of ribs that may beapplied to a device that are neither circumferential nor longitudinaland illustrative that alternative rib patterns may be employed.

Changing characteristics of the treatment device with various ribbingeffects may be performed for a variety of reasons, as an example (andnot to be limited in scope of the invention), one might prefer to changethe base (e.g., unaltered) characteristics of a device to accomplish,for example, a lower profile of the device while mounted on its deliverytool, or during its deployment. Alternatively, one might want to changethe symmetry of the deployed device to open with differentconfigurations to address different anatomical considerations of thetreatment site. For example, one might prefer that a deployed device beplaced predominantly, more medially of an aperture of a annulusfibrosus. Alternatively, it is possible that one might want to increasethe structural integrity of the patch during delivery to provide moreradially directed force into soft tissue, for example nuclear tissue, inorder to better deliver the device into the intervertebral disc. Thedrawings and descriptions of ribs and heat sealing elements, and theresulting beneficial outcomes, above and herein are intended to serve asexamples to altering the configuration through various processes appliedto a device, although, they are only intended to serve as examples, andshould not be considered exhaustive of the advantages of changing thecharacteristics through various heat sealing altering processes, oralternative procedures that apply rib elements to a device.

Heat sealing, in an embodiment of the invention may be used to heatmelt, fasten, or otherwise secure the device ends 606 and 604 of thefilaments of device 600, as discussed previously. Some of the devicesdescribed herein may illustrate end portions as radial (or circular) incross section. However, heat sealing may advantageously allow endportions of devices to have a multitude of configurations which mayaddress various needs of a device and its delivery tools. For example,end portions of the device may be square, oblong, rectangular,triangular, or multi-sided. Heat sealing may readily be performed byheat sealing and otherwise flowing material of the ends of a device overmandrels having the shape of the intended configurations. The heatsealing method may advantageously facilitate construction of endportions in such a fashion. The various shapes are intended to beexemplary, and not limiting in the scope of the invention. Similarly, itis possible that alternative methods to fixate, secure or otherwise formthe ends of the device may also incorporate the different shaped endportions configurations.

Treatment devices throughout the descriptions and illustrationscontained herein may be described as comprising a single braided orwoven body like member, However, it is anticipated that treatmentdevices may contain multiple braided, woven, otherwise patch-likestructures, as illustratively shown in FIGS. 72 and 73. FIG. 72 A showsa treatment device 600′ which may be constructed of two bodies 600, eachof which may appear similar to a device shown elsewhere in thedescription. The form of treatment device 600′ may advantageously allowa treatment device to occupy, in use, a dimension which is greater alonga plane than another plane, as shown in FIG. 72B were device 600′ isdepicted in its deployed configuration. In another illustrative exampleof multiple braided, woven or otherwise patch-like members comprising atreatment device, inner 642 and outer members 644 of braided, woven orpatch-like materials are affixed 646 in the form as shown in FIG.73A-73C. FIG. 73A shows a side view of device 600. FIG. 73B shows across sectional view of device 600, comprising inner body 642 and outerbody 644. FIG. 73C illustratively depicts a form of device 600 asconstructed in FIGS. 73A and 73B in its deployed configuration,advantageously achieving a larger radial profile than device body 642alone. The devices bodies exemplified in FIGS. 72 and 73 may be affixedthrough heat sealing, adhesively bonding, sewing, stitching or othervarious means to attach multiple braided, woven, otherwise patch-likestructures together. The use of multiple body members, and any resultingbeneficial outcomes, above and herein are intended to serve as examplesto altering the construction a treatment device, although, they are onlyintended to serve as examples, and should not be considered exhaustiveof the advantages of employing multiple braided, woven, patch, otherwisemesh-like structures to treatment device.

With regards to introduction, delivery, deployment and/or fixation offixation element 308 as described previously and in particular, withregards to FIGS. 47-56, for example, anchor band assembly 308 and itsassociated delivery tool 400 may be described as effecting a fixation asshown in FIGS. 75A and B. FIG. 75A shows a pledget element 309 that,initially, may be placed on outer annular surface. As depicted, tether318 is attached to pledget 309, and pledget and tether are secured tosuture line 310 via a slip knot 440, for example During deployment,T-anchor is drawn toward, and engaged with, treatment device 600 asillustrated in FIG. 75B. There may be alternative methods and mechanismsof drawing together locking elements/anchors 309 and 316, as exemplifiedin FIG. 74. FIG. 74 illustrates a T-anchor member 316 that may bepositioned, initially, in proximity of patch 600. As depicted, tether318 is attached to T-anchor, and T-anchor and tether are secured tosuture line 310 via a slip knot 440, for example. During deployment,pledget 309 may be drawn to, and engage with, the surface of outerannulus tissue, as illustrated in FIG. 75B. The description of methodsof drawing members together and effecting a fixation of an fixationelement with its fixation element delivery tools are intended to beillustrative, and not limiting in the scope of the invention.

Since the surgeon's visualization of during discectomy procedures istypically limited to the epi-annular space and the aperture at theoutside surface of the annulus, any tactile, visual or audible signalsto assist, or otherwise enhance, the surgeon's ability to reliablydeliver and deploy treatment devices and/or anchor bands may beadvantageous. The anchor band delivery tool 400, may have a patchdetection feature 442 on the distal end of slotted needle cannula 428which may provide perceptible feedback (tactile and/or audible) to thesurgeon that the anchor band delivery tool has accessed and penetratedthe patch and it is therefore acceptable to deliver the band. As shown,detection feature 442 is composed of multiple bands or ribs although theouter surface of needle 428. The movement of the ribs of 442 against thepatch structure (e.g., the filaments of treatment device 600) mayproduce a clicking sound and feel, and the interface of the componentsof the devices and tools may be optimally designed to enhance suchfeedback features. One, or multiple, ribs or tabs may be utilized toachieve the perceptible features. The feed back may be perceived on orwith the patch and/or patch delivery tool or through the anchor bandand/or anchor band delivery tool, or both. FIGS. 70A-70C illustrativelyshows additional means that may be attached to the anchor band or anchorband delivery tool which might also provide perceptible feedback. Thesedepictions are meant to be illustrative and not limiting in scope of theinvention. FIG. 70A shows a tab 442 attached to needle cannula 428 whichmay be laser cut from the distal end of needle 428. Detection tab 442may be designed to readily pass through soft tissue and the patch 600without causing significant disruption, but may be capable due to itsdesign construction to produce tactile and/or audible sensation as itengages the patch lattice or structure. Lateral extent of tab 442 ofFIG. 70A may advantageously deflect, or otherwise deform or bend towardthe distal end of needle cannula upon removal of the delivery tool so asnot to be restricted by the lattice or structure of treatment device 600upon its removal. Alternatively, detection tab 442 of FIG. 70B isaffixed to, or integral with, T-anchor 316. Similarly, detection tab 442may be designed to readily pass through soft tissue and treatment device600 without causing significant disruption, but may be capable ofproducing tactile and/or audible sensation as it engages the patchlattice or structure. In this embodiment, tab 442 advantageously remainswith T-anchor 316 after removal of delivery tool 400. Moreover, it ispossible to have a detection feature 442 as depicted in FIG. 70C whereinthe feature is wholly, or partially, coaxial disposed on the deliverytool and feature 442 may be of a construction that does not readily passthrough patch 600, but it is capable of passing through soft tissue ofthe disc and produce a tactile and/or audible sensation as it engagesthe patch lattice or structure. Although some of the embodimentsillustrate a single tab or rib, it is possible to use more than a singleelement. Detection features described herein may be of a variety ofshapes and affixed to the devices or delivery tools (for example,welding ribs onto the surface of the delivery tool, affixing a flexiblefilament member to the T-anchor) or be incorporated as an integralcomponent thereof (for example, laser cutting or stamping tabs out of aportion of needle 428, injection molding tabs as part of t-anchor 316).Exemplary materials that could be used to construct the variousdetection features include, but are not limited to: biocompatiblepolymeric materials (polyester, polypropylene, polyethylene, polyimidesand derivatives thereof (e.g., polyetherimide), polyamide andderivatives thereof (e.g., polyphthalamide), polyketones and derivativesthereof (e.g., PEEK, PAEK, PEKK), PET, polycarbonate, acrylic,polyurethane, polycarbonate urethane, acetates and derivatives thereof(e.g., acetal copolymer), Polysulfones and derivatives thereof (e.g.,polyphenylsulfone), or biocompatible metallic materials (stainlesssteel, nickel titanium, titanium, cobalt chromium, platinum and itsalloys, gold and it alloys).

As discussed previously, a patch/stent/mesh/treatment device such astreatment device 600 may have element 608 to facilitate the fixing ofthe patch or its ends in a final deployed configuration, if required. Inone exemplary embodiment as shown in FIGS. 29 and 30, a suture with aknot is used to secure ends together after deployment. There may be avariety of ways to latch, lock or otherwise secure the treatment devicein its final configuration, as further depicted in FIG. 71A-G. Thedrawings and description are intended to be illustrative and notlimiting in scope of the invention. It is also anticipated that deliverydevice tools may need to be altered or otherwise reconfigured in orderto accommodate the various latches described. FIG. 71A depicts alatching mechanism that principally involves “press fitting” distalportion/end 606 of treatment device 600 and proximal portion/end 604 oftreatment device 600 onto latching element 608. FIG. 71B shows a“barbed” latching element, wherein proximal end 604 passes over the barbto fixate treatment device in its final configuration. FIG. 71C shows anadditional slot 618 placed in barbed latch of FIG. 71B to facilitate theflexing of latch 608, to accommodate passing end portion 604 over theproximal end of the latch and latching. FIG. 71D shows an embodiment ofa latching device that incorporates a washer 610 to pass over the barbed616 portion of latch 608 to effect the latching and securing the devicein its deployed configuration. In addition, FIG. 71E shows an exemplaryembodiment in which a “flared” region 620 is created by the patchdelivery tool, or other tool, after the proximal end of the patch 604has been passed onto the latch. FIG. 71G shows an alternative method anddevice for latching the patch together incorporating a deformablelatching mechanism. In step one of FIG. 71G, inner latching member isdrawn out as indicated by the arrow 622 to readily allow mesh proximalend 604 to be slidable moved along the latching member 608. Once patchis advantageously positioned in its final configuration, latch membertension is released, lockingly fixing 604 in closer proximity to distalend 606. Optionally, a latch member cutting tool may be integral to thepatch delivery tool to cut latch member 608 to size as shown in stepthree in FIG. 71G (i.e., resect proximal portion of the latch member inclose proximity to proximal end), or if present may be cut with otheravailable tools after delivery of the treatment device.

The latching or securing embodiments described above principally showthe locking effected at, around, or near the proximal portion of thetreatment device. However, it is equally anticipated that these lockingembodiments could be effected on the distal portion of the treatmentdevice, or at both ends simultaneously, as shown in FIG. 71F whereinboth ends of the device are drawn together and locked with separateparts of a two part, or multiple piece, locking mechanism 608.

Latching elements could be constructed from various biocompatiblematerials, such as polymeric materials (for example, polypropylene,polyimide, polyamide, PEEK, polyester, PET polycarbonate urethane, PTFE,polyethylene, engineering plastics), metallic materials (for example,stainless steel, titanium, chromium cobalt alloy, nickel titanium alloy,platinum, gold), bioresorbable of biodegradable materials (for example,material discussed previously for patch or suture materials), naturalmaterials (for example, silk, cotton), or a combination of abovematerials.

FIGS. 76 and 77 further illustrate an additional embodiment of theinvention wherein the device may be used to repair an aperture withinthe intervertebral disc in conjunction with a nuclear augmentationprocedure. The augmentation of the intervertebral disc nucleus mayinclude partial or complete removal of the disc nucleus and possiblyportions of the annulus and other spinal tissues, depending on thedesign of the implant. The prophylactic and/or therapeutic objective ofthese nuclear augmentation implants is to help maintain and/or restorethe normal or natural function of the spinal disc, as described forexample in U.S. Pat. No. 5,976,186 (Bao et al.). The surgical repair ofan intervertebral disc may require the removal of the entire discnucleus being replaced with an implant or a portion of the disc nucleusthereby leaving a void in the intervertebral disc cavity. The volume ofnuclear replacement added to the subannular cavity may be less than,equal to, or larger than disc tissue volume removed. The volume of theimplant may vary over time, depending on the type of replacement oraugmentation device implanted. Although previous embodiments of theinvention described herein could be used to contain implant materialswithin the disc space, FIG. 76 and FIG. 77 illustrate embodiments thatmay more readily accommodate the introduction of injectable, orotherwise flowable, materials into the disc space. Preferably, thematerials would be in situ curable (by way of a number of methods, forexample, chemical, thermal, or photoinitiated), although it is notnecessary that they are. For example, one could introduce a nucleusaugmentation implant comprising small hydrogel particles in an aqueoussuspension that could be delivered to the disc space, with the annularrepair patch 600 retaining the intradiscal material within the discspace. FIGS. 76B and 77 are depicted with nuclear augmentation material218 being introduced into the disc space. FIG. 76A shows a cross sectionview of the delivery of a flowable material 218 from the distal end ofdelivery device 500 as shown by arrow 220. The nuclear replacement maybe introduced through the cannula 526 (as shown in FIG. 58 with rod 514removed) or another cannula of 500, such as 522. As further illustratedin FIG. 76B, the nuclear augmentation material flows, in use, from thedistal end of the delivery tool as shown with arrow 220 and into theintervertebral disc space. FIG. 77 illustrates an alternative method anddevice for the introduction of material 218 into the disc space via thefixation element delivery tool 400. The nuclear augmentation material isinjected and flows from the needle cannula of tool 400 as shown by arrow222, although, other cannulae of tool 400 might also be advantageouslyused to deliver material 218, such as cannula 426. As an alternativeembodiment, using cannula 426 as a delivery conduit, needle cannula 428may be advantageously be retracted as described above, prior to, during,or after the delivery of material through conduit 426. In theembodiments described, flowable and/or injectable material is introducedinto the disc space and the annular treatment device acts to avoid,restrict or other wise reduce the possibility of the implanted materialfrom extruding or migrating from the subannular space. It iscontemplated that one could adapt the delivery tools' construction toaccommodate specific characteristics of a variety of augmentationmaterials, therefore the construction of the delivery tools as depictedare meant to be illustrative, and not limiting.

Flowable, injectable, or otherwise insertable nuclear augmentationmaterials might include natural or synthetic materials comprising:hydrogels, polymers, polymeric precipitates, polymeric emulsions,collagen, fibrin, polymeric protein compositions, poly vinyl alcohols,polysaccharides, cellulose or any derivations of these materials.

As discussed previously, FIGS. 76 and 77 are illustratively intended todepict the introduction of nuclear replacement material 218 to theintervertebral disc, although they may also exemplify methods anddevices to delivery adhesive materials. It is also contemplated thatadditional membrane material may be added to the treatment device tofurther help restrict extravasation of material out of the disc duringaugmentation delivery, if required. Conversely, the treatment deviceconstruction may be altered to reduce the mesh porosity in order toaccomplish a similar objective. Furthermore, it is anticipated thatmaterials maybe added to, or changed, on portions of the delivery toolsto facilitate delivery of the material and removal of the deliverydevices after implant introduction. For example, cannula 526 in FIG. 76may be coated with, or be constructed of, PTFE, FEP, polypropylene,polyethylene or other lubricious materials or coatings. Similarly,portions of delivery device 400 in FIG. 77 may have similar materialtreatments to accomplish the same objective.

As described above, there are a variety of instruments and tools readilyavailable to the surgeon during spine surgery, or other surgicalprocedures, to obtain outcomes intended by the surgeon and the surgicalprocedure. These tools and instruments may be used to: incise, resect,dissect, remove, manipulate, elevate, retract, probe, cut, curette,measure or otherwise effect a surgical outcome. It is anticipated thatsome of these tools and/or instruments may be used before, during, orafter the use of the inventive methods, devices and tools describedherein in order to access, prepare, and/or generally assess treatment,treatment site, or facilitate the manipulation, introduction, ordeployment of the treatment device and/or it's components. Additionaltools and instruments may also be provided to the surgeon to addresssome of these functions. FIG. 65 illustrates one such tool, whereinsizing tool 626, with handle 628 used for tool manipulation, is placedwithin the subannular cavity to probe the subannular space and generallyassess the treatment site prior to delivery of patch, anchor bands orother treatment devices. Generally the length of the device from thetissue stop 634 to the distal end 630 of tool 626 could allow aphysician to measure, or otherwise assess the depth of the cavity andassure sufficient space available as not to cause any untoward events asa result of introduction of the treatment device or its delivery tools.Additional markers 636, preferably radiographically enhanced, may beplaced along distal end of tool to provide indication of the relativecomponents of the treatment device and/or its delivery tools. Forexample, as shown, two markers may identify where the distal andproximal ends of treatment device may be situated, after deployment, ofthe patch. This may be performed prior to introduction of treatmentdevice to the cavity. Proximal end may advantageously contain otherfunctional instruments, helping the surgeon to otherwise manipulate,resect, probe and/or assess the cavity or surrounding tissues, such as aangled curette, as shown in FIG. 65. It is anticipated that instrument626 could be provided as a disposable tool, or a re-sterilizableinstrument. The tool may be advantageously constructed of biocompatiblemetallic materials or polymeric materials, or a combination of both. Asan example, the handle and general construction of the instrument may beformed from a polymer such as: polyester, polypropylene, polyethylene,polyimides and derivatives thereof (e.g., polyetherimide), polyamide andderivatives thereof (e.g., polyphthalamide), polyketones and derivativesthereof (e.g., PEEK, PAEK, PEKK), PET, polycarbonate, acrylic,polyurethane, polycarbonate urethane, acetates and derivatives thereof(e.g., acetal copolymer), polysulfones and derivatives thereof (e.g.,polyphenylsulfone), or the like, whereas markers 636, tissue stop 634,distal 630 and proximal ends 632 could be made of metallic materialssuch as stainless steel, platinum iridium alloys, platinum, titanium,gold, or the like. It is also contemplated that the radiographiccomponents could be deposited (e.g., vapor deposition) or affixed (e.g.,tubular bands attached circumferentially) onto the instrument 626. Thedescription and depiction of tool is intend to illustrative and notlimiting in scope.

Finally, the description and illustrations described previously may bedirected and illustrative of various spinal applications of theinvention, it is possible that the inventive methods, devices anddelivery tools could be applied to the repair, fixation, augmentation,reinforcement, support or otherwise generally prophylactically ortherapeutically treating other tissues. As an example, but not to belimiting the scope of use in other tissues, FIG. 79A-79B illustrate aknee joint in transverse section, containing a meniscus of the knee,anatomically positioned above the Tibia bone 652. The meniscus may bedamaged, torn, weakened, delaminated, degenerated, thin or otherwise inneed of treatment. Fixation elements and/or treatment devices asdescribed herein, may be deployed within the meniscal tissue to effect arepair as shown in FIG. 79B, for example, with two anchor bandassemblies 308 drawing together, and repairing defect 750. It isanticipated within the scope of the invention that methods, devicesand/or delivery tools described herein, and their associated materials,may be adapted to accommodate anatomical and physiologicalcharacteristics involved in repair of the meniscus.

An additional example of using the inventive methods, devices anddelivery tools described herein for the repair, fixation, reinforcement,augmentation, support or otherwise generally prophylactically ortherapeutically treating other tissues is exemplified in FIGS. 80A-80B.FIG. 80A illustrates a general surgical application wherein the contentsof the abdomen may urge the peritoneal cavity to pass out of, orthrough, the femoral ring 660 in proximity of the Inguinal 656 andLacunar 658 ligaments, and otherwise present with symptoms associatedwith a femoral herniation. In FIG. 80A, External Iliac Artery 662 andExternal Iliac Vein 664 are identified for reference purposes. Treatmentdevices, as described herein, may be delivered and applied to repair thefemoral ring area by placing a treatment device just below the femoralring, and the associated Inguinal and Lacunar ligaments surrounding thefemoral ring area. As illustratively shown in FIG. 80B, once treatmentdevice 600 is deployed, one or more fixation elements 308 may be affixedto the patch and the Lacunar and/or Inguinal ligaments to secure thetreatment device, thereby reducing the tendency of the abdominalcontents to urge through the femoral ring area. It is anticipated withinthe scope of the invention that methods, devices and/or delivery toolsdescribed herein, and their associated materials, may be adapted toaccommodate anatomical and physiological characteristics involved in theaugmentation, reinforcement, or otherwise reparation of various femoral,inguinal, umbilical, and incisional hernia.

All patents referred to or cited herein are incorporated by reference intheir entirety to the extent they are not inconsistent with the explicitteachings of this specification, including; U.S. Pat. No. 5,108,438(Stone), U.S. Pat. No. 5,258,043 (Stone), U.S. Pat. No. 4,904,260 (Rayet al.), U.S. Pat. No. 5,964,807 (Gan et al.), U.S. Pat. No. 5,849,331(Ducheyne et al.), U.S. Pat. No. 5,122,154 (Rhodes), U.S. Pat. No.5,204,106 (Schepers at al.), U.S. Pat. No. 5,888,220 (Felt et al.),U.S.Pat. No. 5,376,120 (Sarver et al.) and U.S. Pat. No. 5,976,186 (Bao etal.).

Various materials know to those skilled in the art can be employed inpracticing the present invention. By means of example only, the bodyportions of the stent could be made of NiTi alloy, plastics includingpolypropylene and polyethylene, polymethylmethacrylate, stainless steeland other biocompatible metals, chromium cobalt alloy, or collagen.Webbing materials can include silicone, collagen, ePTFE, DACRON,polyester, polypropylene, polyethylene, and other biocompatiblematerials and can be woven or non-woven. Membranes might be fashioned ofsilicone, polypropylene, polyester, SURLYN, PEBAX, polyethylene,polyurethane or other biocompatible materials. Inflation fluids formembranes can include gases, liquids, foams, emulsions, and can be orcontain bioactive materials and can also be for mechanical, biochemicaland medicinal purposes. The stent body, webbing and/or membrane can bedrug eluting or bioabsorbable, as known in the medical implant arts.

Further, any of the devices or delivery tools described herein, orportions thereof, could be rendered visible or more visible viafluoroscopy, if desired, through the incorporation of radiopaquematerials or markers. Preferably implantable devices are constructedwith MRI compatible materials. In particular, devices and/or theircomponents could be wholly or partially radiopaque, as result of, forexample: compounding various radiopaque materials (e.g., bariumsulphate) into device materials; affixing radiopaque materials to devicestructures (e.g., bands of platinum, gold, or their derivative alloys);deposition of radiopaque materials onto device structures (e.g.,deposition of platinum, gold of their derivative alloys); processingradiopaque materials into device structures (e.g., braiding/weavingplatinum or gold wires or its alloy derivatives). One inventive way toachieve radiopacity of a device described herein, for example treatmentdevice 600, is placing one or more radiopaque marker bands ontofilaments of braided device 600 before (or possibly after) creating endportions of the device.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. A method of treating an intervertebral disc comprising: providing afirst delivery tool having a proximal portion and a distal portion, thedistal portion carrying a treatment device having a first configuration;providing at least one second delivery tool having a proximal portionand a distal portion, the distal portion carrying at least oneaffixation device configured to affix said treatment device to theintervertebral disc tissue; introducing the distal portion of the firstdelivery tool at least partially into the intervertebral disc;introducing the distal portion of said at least one second delivery toolat least partially into the intervertebral disc; deploying at least oneaffixation device into, or through, a portion of the annulus and aportion of the treatment device so as to, at least partially, securesaid treatment device to the intervertebral disc; removing said at leastone second delivery tool; and removing said first delivery tool.
 2. Amethod of claim 1, wherein said affixation device is comprised of one ofmore bands, filaments, lines, wires, tethers or sutures.
 3. A method ofclaim 1, wherein said at least one affixation device comprises at leastone anchor portion and at least one band portion.
 4. A method of claim3, wherein said band portion material is comprised of a mesh tube.
 5. Amethod of claim 1, wherein said affixation device further comprises aconnecting assembly capable of being secured with a retainer, clip,locking element or knot after the process of being shortened.
 6. Amethod of claim 1, wherein said fixation device is secured with a bandlocking device.
 7. A method of claim 1, wherein said treatment devicecomprises material to facilitate regeneration of tissue.
 8. A method ofclaim 1, wherein said affixation device comprises material to facilitateregeneration of tissue.
 9. A method of claim 1, wherein said treatmentdevice comprises a mesh, patch, scaffold, stent, barrier or membrane.10. A method of claim 1, wherein said at least one affixation devicecomprises two anchor portions.
 11. A method of claim 1, wherein said atleast one affixation device comprises two anchor portions.
 12. A methodof claim 11, wherein one anchor portion is disposed, in use, at theouter surface of the annulus, and the second anchor portion is disposed,in use, within the intervertebral disc.